Essential standards of quality and - Care Quality Commission

Guidance about compliance 

Essential standards 

of quality and safety 

What providers should do to comply with the section 20 

regulations of the Health and Social Care Act 2008 

March 2010

About the Care Quality Commission 

The Care Quality Commission is the independent regulator of health 

and adult social care services in England. We also protect the interests 

of people whose rights are restricted under the Mental Health Act. 

Whether services are provided by the NHS, local authorities, private 

companies or voluntary organisations, we make sure that people get 

better care. We do this by: 

● Driving improvement across health and adult social care. 

● Putting people fi rst and championing their rights. 

● Acting swiftly to remedy bad practice. 

● Gathering and using knowledge and expertise, and working 

with others.

How to use this guide 

This guide is designed to help providers of health and adult social care to comply with 

the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 and the 

Care Quality Commission (Registration) Regulations 2009. 

It has two main parts, both of which you need to read: 

Part 1: Preparing to use our guidance 

Step 1 

➜ 

Step 2 

➜ ➜ 

Step 3 

Part 2: Guidance 

l Outcomes 1-28 

Read “About this guide”, which explains why we 

produced this guide, who it is for and how the 

guidance in part 2 is structured 

Select the service types that apply to you 

Read our definitions of key terms that appear 

in the guidance in part 2 

l Prompts that all providers should consider 

l Additional prompts that apply to different service types 

Care Quality Commission: Guidance about compliance Essential standards of quality and safety March 2010 

1

Contents 

Part 1: Preparing to use our guidance 5 

Step 1: About this guide 6 

A new system of registration 6 

The aim of this guide 6 

Why we produced the guidance 7 

Who this guide is for 7 

How we developed the guide 8 

Following our guidance 8 

The regulations that govern your registration 9 

Table of outcome and regulation numbers 10 

Step 2: Select your service types 13 

Step 3: Our definitions of key terms 32 

Checklist before reading the guidance in part 2 38 

Part 2: Guidance 39 

Involvement and information 41 

Outcome 1: Respecting and involving people who use services 42 

Outcome 2: Consent to care and treatment 50 

Outcome 3: Fees 56 

Personalised care, treatment and support 61 

Outcome 4: Care and welfare of people who use services 62 

Outcome 5: Meeting nutritional needs 76 

Outcome 6: Cooperating with other providers 82 

Safeguarding and safety 91 

Outcome 7: Safeguarding people who use services from abuse 92 

Outcome 8: Cleanliness and infection control 102 

Outcome 9: Management of medicines 104 

Outcome 10: Safety and suitability of premises 110 

Outcome 11: Safety, availability and suitability of equipment 120 

2 Care Quality Commission: Guidance about compliance Essential standards of quality and safety March 2010

Suitability of staffing 125 

Outcome 12: Requirements relating to workers 126 

Outcome 13: Staffing 132 

Outcome 14: Supporting workers 134 

Quality and management 141 

Outcome 15: Statement of purpose 142 

Outcome 16: Assessing and monitoring the quality of service provision 144 

Outcome 17: Complaints 150 

Outcome 18: Notification of death of a person who uses services 154 

Outcome 19: Notification of death or unauthorised absence of a person who is detained 

or liable to be detained under the Mental Health Act 1983 158 

Outcome 20: Notification of other incidents 162 

Outcome 21: Records 170 

Suitability of management 175 

Outcome 22: Requirements where the service provider is an individual or partnership 176 

Outcome 23: Requirement where the service provider is a body other than a partnership 180 

Outcome 24: Requirements relating to registered managers 184 

Outcome 25: Registered person: training 188 

Outcome 26: Financial position 192 

Outcome 27: Notifications – notice of absence 194 

Outcome 28: Notifications – notice of changes 198 

Appendices 203 

Appendix A: Glossary 204 

Appendix B: Schedule of Applicable Publications 217 

Appendix C: The Health and Social Care Act 2008 (Regulated Activities) 

Regulations 2010 232 

Appendix D: The Care Quality Commission (Registration) 

Regulations 2009 257 


3


Part 1: Preparing to 

use our guidance 

These are the steps you need to take in order to be able to 

use the guidance set out in part 2 of this document. 

➜ 

Care Quality Commission: Guidance Care about Quality compliance Commission: Essential A quality standards service, of a quality and experience safety – March Guidance 2010 

5


Step 1: 

About this guide 

➜ 

A new system of registration 

As the regulator of health and adult social care in 

England, we make sure that the care that people 

receive meets essential standards of quality and 

safety and we encourage ongoing improvements 

by those who provide or commission care. 

The new registration system for health and adult 

social care will make sure that people can expect 

services to meet essential standards of quality and 

safety that respect their dignity and protect their 

rights. The new system is focused on outcomes 

rather than systems and processes, and places the 

views and experiences of people who use services 

at its centre. 

We will continuously monitor compliance with 

essential standards as part of a new, more 

dynamic, responsive and robust system of 

regulation. Our assessors and inspectors will 

frequently review all available information and 

intelligence we hold about a provider. We will 

seek information from patients and public 

representative groups, and from organisations 

such as other regulators and the National Patient 

Safety Agency. 

If we have concerns that a provider is not meeting 

essential standards of quality and safety, we will 

act quickly, working closely with commissioners 

and others, and using our new enforcement 

powers if necessary. 

6 

Promoting improvement 

In addition to the assurance about compliance 

with essential standards that registration 

will provide, we have an important function 

in promoting improvement by providing 

independent, reliable and timely information 

about the quality of care in providers above 

essential standards, and about the quality of 

care secured by commissioners for their local 

communities, which we describe as assessments 

of quality. 

These assessments include: our periodic reviews 

of the performance of all health and adult social 

care providers, and of councils and primary care 

trusts as commissioners of care; and our special 

reviews and studies of particular aspects of care, 

on economy, efficiency and effectiveness, and 

information issues. 

The aim of this guide 

This guide is designed to help providers of 

health and adult social care to comply with the 

Health and Social Care Act 2008 (Regulated 

Activities) Regulations 2010, and the Care Quality 

Commission (Registration) Regulations 2009. 

These regulations describe the essential standards 

of quality and safety that people who use health 

and adult social care services have a right to 

expect. 

Part 2 of this guide contains the guidance – 

consisting of outcomes and prompts – that 

Care Quality Commission: Guidance about compliance Essential standards of quality and safety March 2010

we have developed to help you comply with 

the regulations. Our guidance is based on the 

outcomes that we expect people using a service 

will experience when the provider is meeting the 

essential standards. 

When developing the outcomes and prompts, we 

have focused on people’s experiences of care, 

and the quality of the treatment and support that 

they receive. People who use services tell us that 

this is what matters most to them, rather than the 

systems, policies and processes needed to deliver 

their care. 

The guidance does not cover the standards that 

individual professionals should achieve in their 

day-to-day practice, because these standards are 

set and enforced by their professional registration 

bodies. For example, the General Medical Council 

and the Nursing and Midwifery Council provide 

such guidance for doctors and nurses. 

Why we produced the 

guidance 

Section 23(1) of the Health and Social Care 

Act 2008 requires us to produce guidance for 

providers of health and adult social care, to help 

them comply with the regulations within the Act 

that govern their activities. 

The Act, the regulations and this guidance are 

part of a wider regulatory framework that includes 

regulation of professionals such as nurses, doctors 

and social workers. The framework is designed to 

ensure that people who use services are protected 

and receive the care, treatment and support 

they need. 

This guidance only relates to providers of services 

that carry on “regulated activities”. These are 

defined in the Health and Social Care Act 2008 

(Regulated Activities) Regulations 2010, which 

are reproduced in appendix C. 

If you are a provider that carries out any 

regulated activities, the framework requires 

you to be registered with the Care Quality 

Step 1: About this guide 

Commission before you carry out these activities. 

The guidance in part 2 of this guide describes the 

outcomes that people using your services should 

be experiencing if you are meeting the essential 

standards required for us to register you. 

We will use the guidance to decide whether to 

register individual providers, and also when we 

monitor their services afterwards to check that 

they are continuing to meet the regulations. 

We will also refer to the guidance when using 

our powers of enforcement to bring about 

improvement in poor services, or to prevent a 

provider from carrying out regulated activities. 

Who this guide is for 

First and foremost, this guide is for people 

working in those health and adult social care 

services that must be registered with us before 

they can legally operate. 

Many of our own staff will also use this guide in 

their day-to-day work. In addition, courts and 

tribunals will take account of part 2 (our guidance 

about compliance) when making decisions about 

our enforcement activities. 

Other groups with an interest in the quality of 

health and social care may find the guidance 

helpful – for example, people who use services, 

other regulators, MPs and the general public. 

We will also produce related information for the 

public about the standards that people should be 

able to expect from services that are registered 

by us. 

Commissioners of services: When councils or 

NHS primary care trusts commission (buy) health 

or adult social care services for the community, 

this is not a “regulated activity” under the 

regulatory framework. This means that our 

guidance does not apply directly to councils 

and primary care trusts as commissioners of care 

services. However, because of its emphasis on 

outcomes for people, we hope that the guidance 

will help them to make decisions about which 

providers to buy services from. 


7


How we developed the guide 

We have developed this guide with the help 

of people who use health and social care 

services, those who provide these services, other 

regulators, and organisations that represent 

people who use services or providers, or that work 

in the wider system of health and social care. 

We carried out a large-scale public consultation, 

asking people what they thought about the draft 

guidance, the way we explained it and the overall 

structure of the document. 

When producing the final version of the 

guidance – part 2 of this document – we have: 

l● Continued to focus on the outcomes, 

experiences and human rights of people who 

use health and social care services. 

l● Used plain English wherever we can. 

l● Stayed within the scope of the regulations. 

l● Applied common standards across both health 

and adult social care services wherever possible. 

l● Provided additional prompts for certain types 

of providers to help them comply with aspects 

of the regulations that relate only to them. 

l● Taken account of relevant legislation and 

standards set by other regulators. 

l● Set out the standards against which we will 

take enforcement action to protect people from 

poor standards of care, treatment and support. 

l● Built on the progress made under the existing 

laws and standards governing health and social 

care in England. 

l● Applied the Government’s principles for better 

regulation. 

Following our guidance 

The detailed outcomes and prompts we provide 

for each regulation indicate what you should 

be doing to meet the requirements of the 

regulations. 

8 

However, you are not legally bound to use 

these. But if you decide to follow alternative 

arrangements, regulation 26 of the Health and 

Social Care Act 2008 (Regulated Activities) 

Regulations 2010 requires you to be able to 

demonstrate that you have taken account of the 

outcomes and prompts in this document when 

judging your compliance with the regulations in 

your day-to-day activities. We must be sure that 

your services are meeting the essential standards 

of quality and safety before we can register you. 

If you choose not to use the prompts, you will still 

need to be able to show us that you are meeting 

the needs of people using your services, and to 

the standards that the regulations require. If you 

do not do so, we will ask you to explain why. 

If you feel you cannot follow our prompts because 

your services are particularly innovative and the 

evidence you will want to provide will be different 

from that which the prompts indicate, we will 

work with you to confirm that your services are 

reaching the essential standards of quality and 

safety. 

How we have structured the guidance 

Before developing the outcomes expected for 

compliance with each of the regulations, we 

grouped the regulations into six key areas. 

These are: 

l● Involvement and information 

l● Personalised care, treatment and support 

l● Safeguarding and safety 

l● Suitability of staffing 

l● Quality and management 

l● Suitability of management. 

The guidance in part 2 contains a section for each 

area, containing: 

l● A summary of the area and the regulations that 

it includes. 

l● For each regulation: 


– the text of the regulation 

– what we think people who use services 

should experience when providers comply 

with the regulation (the definition of the 

outcome). This is what we will focus on when 

we check that providers are meeting 

essential standards 

– detailed prompts to help providers achieve 

this outcome, divided into sub-sections to 

make it easier to follow. We do not expect 

providers to use these prompts as a checklist, 

but they can help providers to identify if 

they are meeting the outcome. 

Before you read any of the detailed prompts, 

make sure that you have read step 2 (page 13) 

so that you can identify and record which ‘service 

types’ your regulated activities fall under. You 

need to follow this step because the detailed 

prompts are of two types: 

– Prompts that apply to all providers. 

– In addition, prompts that only apply to 

specific service types. 

Do I need to read all of the outcomes? 

In some instances, our expectations for an 

outcome may apply to a number of other 

outcomes. For example, Outcome 14 about 

supporting workers is the main part of the 

guidance that addresses staff training. But for 

providers to achieve the outcomes needed for, 

say, nutrition or safeguarding, they may need to 

meet staff training requirements in these areas. 

Therefore, we strongly recommend that you read 

all of the outcomes relevant to you in part 2. 

What type of evidence do I need to 

provide? 

The outcomes that we set out in the guidance 

are the same for all providers within each service 

type. However, the way that providers demonstrate 

that they are achieving these outcomes may differ 

according to their size, structure and governance. 

Your evidence may be influenced by: 

l● The size of your service. 


l● The range and complexity of the services you 

provide. 

l● The needs and number of people who use your 

services. 

l● The range of staff you employ and how they 

work together to meet the needs of people 

who use your service. 

l● The systems you have to produce information, 

for example computer systems, audit processes 

or being part of a national or regional structure. 

You will not routinely need to provide 

evidence for the prompts. These are supplied 

to help you comply with the regulations. 

The regulations that govern 

your registration 

When we refer to “the Act” in this document, 

we mean the Health and Social Care Act 2008. 

The specific regulations that govern your 

registration are the Health and Social Care Act 

2008 (Regulated Activities) Regulations 2010 

and the Care Quality Commission (Registration) 

Regulations 2009. 

Section 23 of the Act requires us to produce 

guidance about some of these regulations. These 

are called ‘section 20 regulations’ and this guidance 

only relates to those. However, we have reproduced 

all of the regulations in appendices C and D. 

The table on pages 10-11 shows how the 

regulations and the outcomes link together in the 

guidance. 

The legal status of our guidance for 

providers 

Although we must take it into account when 

making decisions about a provider’s compliance 

with the regulations and in tribunals and courts, 

the guidance is not enforceable in its own right. 


9


Involvement and information 

Outcome 1: Respecting and involving people who use services 

Outcome 2: Consent to care and treatment 

Outcome 3: Fees 

Personalised care, treatment and support 

Outcome 4: Care and welfare of people who use services 

Outcome 5: Meeting nutritional needs 

Outcome 6: Cooperating with other providers 

Safeguarding and safety 

Outcome 7: Safeguarding people who use services from abuse 

Outcome 8: Cleanliness and infection control 

Outcome 9: Management of medicines 

Outcome 10: Safety and suitability of premises 

Outcome 11: Safety, availability and suitability of equipment 

Suitability of staffing 

Outcome 12: Requirements relating to workers 

Outcome 13: Staffing 

Outcome 14: Supporting workers 

Quality and management 

Outcome 15: Statement of purpose 

Outcome 16: Assessing and monitoring the quality of service provision 

Outcome 17: Complaints 

Outcome 18: Notification of death of a person who uses services 

Outcome 19: Notification of death or unauthorised absence of a person who is detained 

or liable to be detained under the Mental Health Act 1983 

Outcome 20: Notification of other incidents 

Outcome 21: Records 

Suitability of management 

Outcome 22: Requirements where the service provider is an individual or partnership 

Outcome 23: Requirement where the service provider is a body other than a partnership 

Outcome 24: Requirements relating to registered managers 

Outcome 25: Registered person: training 

Outcome 26: Financial position 

Outcome 27: Notifications – notice of absence 

Outcome 28: Notifications – notice of changes 

10 

4 5 6 7 9 


Health and Social Care Act 2008 

(Regulated Activities) 

Regulations 2010 


Care Quality Commission 

(Registration) Regulations 2009 

Regulation number Regulation number 

10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 12 13 14 15 16 17 18 19 


11


Regulation of the requirement 

to prevent or control healthcareassociated 

infections 

The Care Quality Commission is not required by 

the Act to produce guidance about legislation 

governing the prevention or control of 

healthcare-associated infections (regulation 12 of 

the Health and Social Care Act 2008 (Regulated 

Activities) Regulations 2010). This guidance 

is available in the Department of Health’s 

publication: The Code of Practice for health and 

adult social care on the prevention and control of 

infections and related guidance. 

Other relevant legislation 

The Act allows us to take account of a provider’s 

compliance with any other legislation that we 

believe is relevant to registration. In our prompts, 

we specify other legislation that we consider to 

be of particular importance, but we have not 

included all relevant legislation. 

As a provider of care, you are responsible for 

knowing what other legislation is relevant to your 

service and making sure that you comply with 

it. We may consider your compliance with such 

legislation as part of the way we monitor and 

check your services. 

As well as making sure that you are aware of 

other relevant legislation, you should read 

the Schedule of Applicable Publications in 

appendix B. 

12 


➜ 

Step 2: Select your service types 

Step 2: 

Select your service types 

Before you can use the detailed prompts in part 2, you need to decide which 

of our 28 coded service types your activities fall under. You may find that 

your activities span a number of different service types. 

Please make sure that you identify all of the service types that apply to you, 

and then make a record of their codes. It is important that you carry out this 

step accurately before reading the guidance in part 2, because the prompts 

include additional sections that only apply to certain service types and are 

coded accordingly. If you ignore or rush this step, you may miss some 

prompts that would have helped you comply with one or more of the 

regulations. 

The service types and their codes are not necessarily ‘industry standard’ 

terms – we have simply used them to make the prompts easier for you to 

navigate. 

You can use the following table to tick which of the service types apply 

to you. 

ACS AMB BTS CHC CHN CHS DCC 

DCS DEN DSS DTS EXC HBC HPS 

LDC LTC MBS MHC MLS PHS RCA 

RHS RSM SHL SLS SMC SPC UCS 


13


Healthcare services 

Code: Service type: 

ACS Acute services 

14 

These services are complex and vary greatly. Generally, however, they provide 

medical and/or surgical investigations, diagnosis and treatment for physical 

illness or condition, injury or disease. 

They can provide services to adults, children or both. They may provide 

services to a broad range of people or to a particular group of people. 

They can: 

l● Admit people on a day case basis or as inpatients. 

l● Admit people at short notice or in an emergency (whether or not they have 

a dedicated emergency department). 

l● See people on an outpatient basis. 

They may also provide services such as: 

l● Surgical operations 

l● Specialist medical treatments 

l● Emergency 

l● Consultations 

l● Diagnostics 

l● Maternity and neonatal 

l● Pathology 

l● Termination of pregnancy 

l● Complex dental procedures 

l● Liaison psychiatry. 

People are usually admitted to the service under the care of a medical or 

clinical practitioner. The service may also employ a broad range of healthcare 

professionals to meet the needs of the people using the service. 

Some services may be smaller than others and may not provide the same 

range of acute services than, say, a local district hospital may offer (such as 

an emergency department). 



ACS Acute services (continued) 

Examples of services that fit under this category 

l● Acute NHS hospitals 

l● Acute independent hospitals 

l● Termination of pregnancy clinics 

l● NHS community hospitals 

l● Independent sector treatment centres (ISTCs) 

l● Community hospitals 

l● Cosmetic surgery clinics 

l● Specialist or single specialty hospitals 

l● Maternity hospitals. 

l● IVF clinics providing surgical treatment or endoscopy 

l● Haemodialysis units 

l● Minor injuries units 

HBC Hyperbaric chamber services 


These services involve the administration of oxygen (whether or not 

combined with one or more other gases) to a person in a sealed chamber that 

is gradually pressurised with compressed air. The services are carried out by, or 

under the supervision of, a medical practitioner. 

The services help to treat a range of medical conditions including: 

l● Air or gas embolism 

l● Decompression illness 

l● Carbon monoxide poisoning 

l● Gas gangrene 

l● Necrotising fasciitis 

l● Other conditions approved by the Undersea and Hyperbaric Medical 

Society. 


l● Type 1 hyperbaric chambers 

l● Type 2 hyperbaric chambers 


15



HPS Hospice services 

16 

These provide a range of services for conditions where curative treatment is 

no longer an option, and people are approaching the end of their life. They 

provide care, treatment and support for people and their families and carers, 

including respite care for people who live with friends or family at home. 

Care, treatment and support can be provided in accommodation or in the 

community. It can be long or short-term care, on an inpatient basis or 

provided through day care, day therapy or outreach services. 

The services will generally employ or work with a broad range of health and 

social care professionals to meet the needs of people using the service. 


l● Adult hospices 

l● Children’s hospices 

l● Day hospices 

l● End of life care teams 

l● Hospice at home 

LTC Long-term conditions services 

These services provide a range of care, treatment and support to people with 

physical or neurological illnesses, cognitive impairments or injuries that are 

unlikely to improve. These conditions may have been inherited or acquired, 

and may not necessarily be life-limiting. This care, treatment and support is 

the sole or main purpose of the service. 

People may be cared for by these services for many years at a time, and will 

be ‘admitted’ and stay at the facility over time. People using these services 

require the support of medical practitioners and a range of other healthcare 

professionals, and their care, treatment and support may involve highly 

technical interventions such as ventilation. 




MLS Hospital services for people with mental 

health needs, and/or learning disabilities, 

and/or problems with substance misuse 

These services are for people with mental health needs or learning 

disabilities, who are admitted to hospital, involving an overnight stay, for 

assessment or treatment when there is a need for more intensive support 

than would typically be provided in the community, or a need for a specialist 

assessment or intervention. 

This usually occurs due to: 

l● An acute episode of a severity that requires 24-hour care. 

l● A need for a higher level of security. 

l● A need for a specialist assessment, treatment and/or rehabilitation. 

This might include providing care, treatment and support for people detained 

under the Mental Health Act 1983. 

Some people with mental health needs or a learning disability may require 

longer-term accommodation in hospital, while others may be admitted for 

short periods or treated on a day case basis. 

These services also cover inpatient treatment for people with problems 

with substance misuse. They usually involve short periods of hospitalbased 

treatment, including 24-hour medical cover to assess and stabilise the 

person, and treatment for withdrawal from drugs (legal, illegal and substitute 

preparations) or detoxification from alcohol. 

All the hospital services above will usually comprise one or more wards in 

which care, treatment and support is provided. There may be a range of other 

facilities including occupational and arts therapies, psychological therapies, 

psychosocial interventions, recreational activities and services to address 

physical health needs. 


l● NHS or independent services that provide specialist hospital services for 

people with mental health needs, learning disabilities and problems with 

substance misuse 

l● Child and adolescent mental health services (CAMHS) tier 4 


17



PHS Prison healthcare services 

18 

These services offer a primary care type of service in a prison, usually in 

a health centre or similar setting. They may include GP, dental, optician, 

chiropody, genito-urinary medicine, general medicine and physiotherapy 

services, as well as some outpatient clinical sessions held in the prison. 

The services in prison usually consist of teams of registered nurses (RN) 

who are on either the adult, mental health or learning disability parts of the 

register and, where children are concerned (that is, mother and baby units) 

health visitors and midwives. 

Some prison health services have inpatient facilities, which are not considered 

‘hospitals’. These will care for people with physical ill health or mental health 

needs who are not ill enough to need specialist care, treatment and support 

in secondary care services. If the person’s condition worsens, they would be 

immediately sent out to external NHS hospitals and not returned to prison 

unless deemed clinically well enough to be discharged. 

The services may also provide care, treatment and support for people with 

mental health needs through multi-disciplinary in-reach teams. These teams 

offer a similar range of specialist care, treatment and support as provided by 

community-based mental health services. 

The services may also provide substance misuse treatment and 

rehabilitation services for people who misuse drugs and/or alcohol. They 

provide counselling, assessment, referral, advice and through-care, both 

pharmacological and psychosocial. They employ a broad range of health and 

social care professionals to meet the needs of people who use their services. 


l● Type 1 prison healthcare services: daytime cover, generally by part-time 

staff (no inpatient facilities) 

l● Type 2 prison healthcare services: daytime/24-hour cover, generally by 

full-time staff (no inpatient facilities) 

l● Type 3 prison healthcare services: healthcare centre with 24-hour nurse 

cover, usually with inpatient facilities 

l● Type 4 prison healthcare services: as type 3 but also serving as a national or 

regional assessment centre, used by other prisons 

l● Mental health in-reach teams 

l● Counselling, assessment, referral, advice and through-care (CARAT) teams 

l● Prison drug rehabilitation programmes 

l● Young offenders institutions 

l● Some immigration removal centres 



RHS Rehabilitation services 


These services provide, as their sole or main purpose, treatment to people 

following an illness or injury that impairs their physical, mental or cognitive 

wellbeing, but for which continued rehabilitative care is likely to bring about 

improvement. 

They may consist of a range of services that promote faster recovery from 

illness, prevent unnecessary admission to acute services, support timely 

discharge and maximise independent living. 

The services can be provided on a short or long-term basis, in hospital, 

residential, day care or domiciliary settings. They are mainly provided within 

healthcare settings but can also be provided in a social care setting. 


l● Intermediate care schemes 

l● Rehabilitation units 

RSM Residential substance misuse treatment/ 

rehabilitation services 

These services are provided to adults and children who have problems with 

misusing drugs and/or alcohol. They provide care, treatment and support, 

both pharmacological and psychosocial, and help people to reintegrate into 

their communities, focusing on the coping strategies and life skills they need 

to do this. They employ a broad range of health and social care professionals 

to meet the needs of people who use their services. 

Some of these services may also provide assessment, stabilisation 

and treatment for withdrawal from drugs (legal, illegal and substitute 

preparations) or detoxification from alcohol. 


l● Residential substance misuse rehabilitation services 

l● Crisis intervention units 

l● Care homes providing accommodation for the treatment of substance 

misuse 


19


Community or integrated healthcare 


CHC Community healthcare services 

20 

These services supply a range of healthcare staff other than doctors, for 

example nurses or allied health professionals, to people who need healthcare 

support in their own home, in community settings or in child development 

units. 

The care provided may be short or long term, and meet acute or chronic 

healthcare needs. The services may help people to live independently in the 

community and they are directly responsible for the quality of the care and 

support provided by the staff they supply, and do not include employment 

agencies. 


l● District nursing 

l● Nurses agency 

l● Community physiotherapy team 

l● Health visiting team 

l● Support worker team 

l● Children’s community nurses 

l● Community paediatric therapies 

l● Community midwifery 

l● School nursing 

l● Family planning and sexual health clinics 

l● Community rehabilitation teams 

DCS Doctors consultation services 

These services involve doctors working in premises, or a room, designated for 

medical consultation. Often the doctor will complete medical consultations, 

including physical examination and simple physiological measurement (such 

as blood pressure tests). They will discuss diagnosis and treatment options 

and may prescribe medicines for the person to take at home. 

There may be other healthcare professionals, for example nurses, supporting 

the work of the doctor. 


l● Independent doctors consulting rooms 

l● NHS GP practice 

l● Slimming clinics 



DTS Doctors treatment services 


These services involve doctors working in premises, or a room, designated for 

minor medical treatments as well as medical consultation. Often the doctor 

will complete medical consultations, including physical examination and 

simple physiological measurement (such as blood pressure tests). They will 

discuss diagnosis and treatment options and may prescribe medicines for the 

person to take at home. 

They will also undertake minor invasive investigations or procedures, such as 

conscious endoscopy, in a treatment room designed for this purpose. 


the work of the doctor. 


l● Independent doctors consulting rooms 

l● NHS GP practice 

l● Early medical abortion clinics 

l● Travel vaccination services 

l● Polyclinics 

DEN Dental services 

These services involve registered dentists and dental care professionals 

usually working in premises designed for consultation and treatments, but 

can also be provided in a person’s place of residence. Consultations and 

examinations will involve discussion of the treatment options with the 

patient and may include dental radiography. Treatment is usually provided 

in a dedicated room and, in consultation with the patient, may be under 

local anaesthetic or use a laser. Medicines may be prescribed as part of the 

treatment. 


l● NHS dental practice (directly provided by a primary care trust) 


21



DSS Diagnostic and/or screening services 

22 

These services provide individual health assessment and/or screening to 

people, using: 

l● Diagnostic imaging, such as: 

– X-rays 

– Computed tomography (CT) 

– Magnetic resonance imaging (MRI) 

– Ultrasound scanning 

– Gamma cameras 

– PET scanners 

l● Pathology 

l● Physiological measurement 

l● Genetic and screening services 

l● Endoscopy. 

They provide, as the sole or main purpose, diagnosis or screening. They 

do not usually provide any other health or social care services. While large 

acute hospitals will have similar services, this category relates only to these 

dedicated, focused services. 

These services undertake investigations on behalf of the person using the 

service or on behalf of a healthcare professional that the person is consulting 

(who is legally permitted to request such investigations). 

They will involve a range of healthcare professionals that may include: 

l● Medical practitioners 

l● Nurses 

l● Radiographers 

l● Physiological measurement technicians. 


l● Health screening centres 

l● MRI or CT scanning services (fixed and mobile) 

l● Baby scanning services 

l● Endoscopy centres and clinics 

l● Stand alone or mobile urodynamic services. 




LDC Community-based services for people with a 

learning disability 

These services provide care, treatment and support in the community for 

people with a learning disability, through a wide range of service models. 

They employ a broad range of health and social care professionals mainly in 

multi-disciplinary teams. 

They help people to live as independently as possible, manage their condition 

and improve it where this is possible. People using these services may receive 

support over a long period of time or for short-term interventions. They may 

move between the various community teams to ensure that their changing 

needs are met. 


l● Community learning disability teams 

l● Challenging behaviour/outreach teams 

MBS Mobile doctors services 

These services involve doctors working in premises where the person using 

the service is living (on a long or short-term basis). They may also provide 

services via an internet website where the initial consultation is with a doctor. 

The doctors provide medical consultations, including physical examination 

and simple physiological measurement (such as blood pressure tests). They 

will discuss diagnosis and treatment options and may prescribe medicines for 

the person to take at home. 


the work of the doctor, but this is less likely. 


l● Independent medical agencies 

l● GP out-of-hours services 

l● Community doctor 

l● Internet-based diagnosis or prescription service 


23



MHC Community-based services for people with 

mental health needs 

24 

These services provide care, treatment and support in the community for 

people with mental health needs, through a wide range of service models. 

They employ a broad range of health and social care professionals mainly in 

multi-disciplinary teams. 

They help people to recover by providing a broad range of interventions 

reflecting the psychological, social and physical needs of the individual. 

People using these services may receive support over a long period of 

time or for short-term interventions. They may move between the various 

community teams to ensure that their changing needs are met, or be in 

contact with them simultaneously. 

This may include providing care, treatment and support to people subject to 

supervised community treatment under the Mental Health Act 1983. 


l● Child and adolescent mental health services (CAMHS) (tiers 2, 3 and 4) 

l● Community-based services that provide assessment and treatment for 

people with mental health needs including: 

– community mental health teams 

– assertive outreach 

– early intervention teams 

– court diversity teams 

– crisis resolution home treatment teams 

SMC Community-based services for people who 

misuse substances 

These services are provided in the community for people who misuse 

drugs and/or alcohol. They provide care, treatment and support, both 

pharmacological and psychosocial, and help with social and other needs so 

that people can reintegrate into their communities. They employ a broad 

range of health and social care professionals to meet the needs of people who 

use their services. 


l● Community drug and alcohol teams 

l● Criminal justice intervention teams 



UCS Urgent care services 


These services are provided in parallel with an emergency department and 

vary greatly from one service to another. They generally comprise a triage 

service, run by doctors and nurses. 

They will not usually screen people whose symptoms require immediate, very 

urgent or emergency care. Instead, they screen standard cases where time is 

not of the essence, and where possible refer these for immediate consultation 

with an on-site primary care provider. 

They may provide services such as: 

l● Consultations with a doctor 

l● Physical examinations and simple physiological testing and measurement 

l● Diagnosis and treatment 

l● Prescribing medicines 

l● Referrals to other primary care services. 


l● Primary care trust emergency triage 

l● Urgent care triage 

l● Primary care access centre 

l● Walk-in clinic 


25


Residential social care 


CHN Care home services with nursing 

26 

A care home is a place where personal care and accommodation are provided 

together. People may live in the service for short or long periods. For many 

people, it is their sole place of residence and so it becomes their home, 

although they do not legally own or rent it. Both the care that people receive 

and the premises are regulated. 

In addition, qualified nursing care is provided, to ensure that the full needs of 

the person using the service are met. 


l● Nursing home 

l● Convalescent home with nursing 

l● Respite care with nursing 

l● Mental health crisis house with nursing 

CHS Care home services without nursing 

A care home is a place where personal care and accommodation are provided 

together. People may live in the service for short or long periods. For many 

people, it is their sole place of residence and so it becomes their home, 

although they do not legally own or rent it. Both the care that people receive 

and the premises are regulated. 


l● Residential home 

l● Rest home 

l● Convalescent home 

l● Respite care 

l● Mental health crisis house 

l● Therapeutic communities 



SPC Specialist college services 


These services provide education, care and training in independence for 

young people with learning disabilities and/or physical disabilities. The 

colleges are first and foremost educational establishments and are regulated 

by Ofsted. The personal care and accommodation provided by a college 

is regulated by the Care Quality Commission where 10% or more of the 

students require personal care. 


27


Community social care 


DCC Domiciliary care services including those 

provided for children 

28 

These services provide personal care for people living in their own homes. The 

needs of people using the services may vary greatly, but packages of care are 

designed to meet individual circumstances. 

The person is visited at various times of the day or, in some cases, care is 

provided over a full 24-hour period. Where care is provided intermittently 

throughout the day, the person may live independently of any continuous 

support or care between the visits. 


l● Domiciliary care agency 

EXC Extra Care housing services 

These services cover many different arrangements. Usually, they consist 

of purpose built accommodation in which varying amounts of care and 

support can be offered, and where some services and facilities are shared. 

The care people receive is regulated by the Care Quality Commission, but the 

accommodation is not. 



SHL Shared Lives (formerly known as 

Adult Placement) 


Shared Lives is care and/or support provided by individuals, couples and 

families who have been approved and trained for that role by the service 

registered with Care Quality Commission. Care and/or support may also be 

provided either within or outside of the home of the carer as well as kinship 

support to people living in their own homes. It is the service that is regulated 

not the individual accommodation which is owned or rented by private 

residents. 

SLS Supported living services 

These services involve a person living in their own home and receiving care 

and/or support in order to promote their independence. The care they receive 

is regulated by the Care Quality Commission, but the accommodation is 

not. The support that people receive is continuous, but is tailored to their 

individual needs. It aims to enable the person to be as autonomous and 

independent as possible, and usually involves social support rather than 

medical care. 


29


Miscellaneous healthcare 


AMB Ambulance services 

30 

These services include both the provision of emergency response and 

transport services. They may include patient transport services as well as 

emergency vehicles used to transport people, including ambulances. They 

may provide care, treatment and support and employ a range of healthcare 

professionals to meet the needs of the people who use the service. 


l● Emergency ambulance services 

l● Patient transport services 

BTS Blood and transplant services 

The management of the supply of blood, blood-derived products and 

biologically derived tissues to a healthcare provider for the purposes of 

administering, grafting or transplantation into a human being. 


l● NHS Blood and Transplant 



RCA Remote clinical advice services 


These services provide, as their sole or main purpose, a range of clinical 

services to people from a distance in an urgent or emergency situation. The 

initial consultation is usually with a registered nurse. They may provide care, 

treatment and support to people using: 

l● Telephone systems 

l● Digital systems 

l● E-mail. 

The services may include: 

l● Simple clinical advice and reassurance 

l● Diagnosis 

l● Health screening 

l● Prescription of medicines 

l● Referral to another clinical service. 

These services may provide some face-to-face support, but this is not their 

primary purpose. 


l● NHS Direct 


31


Step 3: 

Our definitions of key terms 

➜ 

The key terms shown below will be familiar to providers of health and social 

care services. However, it is important that you understand our intended 

meaning when we use them in our guidance. You will also need to refer to 

these definitions when reading and applying the guidance. In addition, the 

glossary in appendix A has definitions for more words and phrases. 

Equality, diversity and 

human rights 

Providers must consider equality, diversity and 

human rights in every aspect of their work. You 

should consider the needs of each person using a 

service against six key strands of diversity: 

l● Race 

l● Age 

l● Gender 

l● Disability 

l● Sexual orientation 

l● Religion or belief. 

We sometimes refer to this as identifying a 

person’s “diversity” or “diverse needs”. 

32 

People who use services 

“People” includes everyone, but sometimes the 

guidance only relates to certain groups of people. 

Where this is the case we state the group that 

it relates to – for example, children, people with 

mental health needs and people with a learning 

disability. 


Those acting on behalf of the 

person using services 

The outcomes and prompts refer to others acting 

on behalf of the person using services. They may 

be: 

l● A carer 

l● The next of kin 

l● A parent 

l● A friend, partner, neighbour or other relative 

l● An Independent Mental Capacity Advocate 

l● An Independent Mental Health Advocate 

l● A Relevant Persons Representative (DoLS) 

l● An Advocate 

l● An attorney 

l● The nearest relative – in relation to the Mental 

Health Act 

l● Corporate parent 

l● A member of staff acting informally. 

To meet a person’s needs, you must assess and 

understand when support from another person 

would be helpful to them. You must balance 

the right of the person to make decisions for 

themselves with the need, appropriateness 

or desire of the other person to be involved. 

However, this should never mean that the 

individual voice of the person using the service is 

lost, or that their choices are diluted when they 

are competent to make them. 

Step 3: Our definitions of key terms 

Carers 

The focus of the regulations is on the safety 

and wellbeing of people who use services, and 

therefore the outcomes and prompts do not 

address the specific needs of carers. However, 

it recognises carers acting on behalf of people 

who use services and where care, treatment and 

support is transferred to, or shared with, carers. 

A carer is one of the list of people above who may 

act on behalf of the person using the service. 

We encourage you to understand, value and 

respect the important work that carers do, often 

with no recognition, and work cooperatively with 

carers when meeting the needs of the people who 

use your service. 

Involvement 

When the guidance refers to “involving” people 

who use services, we mean enabling people to get 

involved in the planning and delivery of their own 

care, treatment and support. This includes people 

acting on their behalf and groups of people 

who use services being involved together, for 

example through local involvement networks or a 

user forum. 

However, in this guidance involvement does not 

mean the involvement of a service’s community 

more widely and the involvement of people 

who may, at the time, be only potential users of 

services, for example the population served by an 

NHS acute hospital. Other legislation may place a 

requirement on them to do so. 


33


“People who use services 

understand…” 

People who use your services need to understand 

the care, treatment and support that they will 

receive. You must give them the information 

they need to help them understand the choices 

available to them, and to enable them to make 

informed decisions. 

Sometimes, the person will not be able to 

‘understand’ the choices available to them or 

the decisions they need to make. This may be 

because their ability to understand is limited by 

a long-term condition, their age or particular 

circumstances at the time. You must meet the 

person’s interests by making every effort to help 

them to understand as much as they can. 

Information 

Providing information to people who use services 

means that it must be given in a way they can 

understand, whatever their communication needs 

may be. 

This does not necessarily mean that all 

information has to be routinely translated into 

different languages or formats (for example 

Braille, Easy Read or sign language). However, 

important information should be presented in any 

alternative formats needed to meet the different 

communication needs of the people who use your 

services. You must identify these communication 

needs for the people who use your services and 

ensure that you meet them. 

34 

Capacity and deprivation of 

liberty safeguards 

The outcomes and prompts assume that people 

using your services have capacity to make their 

own choices and decisions independently. Where 

this is not the case, you must support the person 

in line with: 

l● The Human Rights Act 1998 

l● The Mental Health Act 1983 

l● The Mental Capacity Act 2005 

l● Deprivation of Liberty Safeguards 

l● The Children Act 1989 and Fraser competency. 

Abuse 

The outcomes and prompts describe what you 

need to do to safeguard children and adults. 

We believe that a person’s right to live a life 

free from abuse and neglect, and for abuse to 

be prevented, is as important as responding 

to it after it has happened. The legislation 

and government guidance about child abuse 

is different from that for adult abuse. The 

regulations state that you must take account of 

the Government’s guidance. 

For children’s safeguarding, the definitions we 

use are taken from Working Together to safeguard 

Children (HM Government, 2006). We have 

reproduced them below: 

Abuse and neglect: Abuse and neglect are 

forms of maltreatment of a child. Somebody 

may abuse or neglect a child by inflicting harm, 

or by failing to act to prevent harm. Children 

may be abused in a family or an institutional or 

community setting, by those known to them or, 

more rarely, by a stranger. They may be abused by 

an adult or adults, or another child or children. 


Physical abuse: May involve hitting, shaking, 

throwing, poisoning, burning or scalding, 

drowning, suffocating, or otherwise causing 

physical harm to a child. Physical harm may also 

be caused when a parent or carer fabricates the 

symptoms of, or deliberately induces, illness in 

a child. 

Emotional abuse: The persistent emotional 

maltreatment of a child such as to cause severe 

and persistent adverse effects on the child’s 

emotional development. 

Sexual abuse: Involves forcing or enticing a child 

or young person to take part in sexual activities, 

including prostitution, whether or not the child 

is aware of what is happening. The activities may 

involve physical contact, including penetrative 

or non-penetrative acts. They may include noncontact 

activities, such as involving children in 

looking at, or in the production of, sexual online 

images, watching sexual activities, or encouraging 

children to behave in sexually inappropriate ways. 

Neglect: The persistent failure to meet a child’s 

basic physical and/or psychological needs, likely 

to result in the serious impairment of the child’s 

health or development. 

For adult safeguarding, the definitions we use 

are taken from No Secrets (Department of Health 

and the Home Office, 2000). We have reproduced 

them below: 

Abuse is a violation of an individual’s human and 

civil rights by other person or persons. Abuse 

may consist of single or repeated acts. It may be 

physical, verbal or psychological, it may be an act 

of neglect or an omission to act, or it may occur 

when a vulnerable person is persuaded to enter 

into a financial or sexual transaction to which 

he or she has not consented, or cannot consent. 

Abuse can occur in any relationship and may 

result in significant harm, or exploitation of, the 

person subjected to it. 


Of particular relevance are the following 

descriptions of the forms that abuse may take: 

Physical abuse: including hitting, slapping, 

pushing, kicking, misuse of medication, restraint, 

or inappropriate sanctions. 

Sexual abuse: including rape and sexual assault 

or sexual acts to which the vulnerable adult 

has not consented, or could not consent or was 

pressured into consenting. 

Psychological abuse: including emotional 

abuse, threats of harm or abandonment, 

deprivation of contact, humiliation, blaming, 

controlling, intimidation, coercion, harassment, 

verbal abuse, isolation or withdrawal from services 

or supportive networks. 

Financial or material abuse: including theft, 

fraud, exploitation, pressure in connection 

with wills, property or inheritance or financial 

transactions, or the misuse or misappropriation of 

property, possessions or benefits. 

Neglect and acts of omission: including 

ignoring medical or physical care needs, failure to 

provide access to appropriate health, social care 

or educational services, the withholding of the 

necessities of life, such as medication, adequate 

nutrition and heating. 

Discriminatory abuse: including racist, sexist, 

that based on a person’s disability, and other 

forms of harassment, slurs or similar treatment. 

Subjective terms 

We have tried not to use subjective terms such 

as “so far as they are able” or “wherever this is 

possible”. Sometimes this has not been possible. 

This does not mean that you can make a general 

decision about whether the outcome is valuable 

or worth achieving. 


35


Care, treatment and support 

The outcomes and prompts often refer to the 

needs of people who use services being met 

through “care, treatment and support”. This 

is a general term that we use to refer to the 

things that providers do to meet people’s needs, 

although we realise that in some cases people 

may not receive actual ‘treatment’ and in others 

they may only receive support. 

The level of care, treatment and support that 

each person requires will depend on their 

individual health and social care needs. It includes 

actions taken to prevent illness or disease and to 

promote lifestyles that maintain health. 

Shared Lives 

We talk about services provided under an adult 

placement scheme as “Shared Lives”. 

Provider 

There are several legal terms relating to the 

providers of services. These include Registered 

Person, Service Provider and Registered Manager. 

The term “provider” means anyone with a legal 

responsibility for ensuring the requirements of the 

law are met. 

36 

Fitness 

The law uses the word “fit” in relation to staff and 

workers to mean two things. Firstly, it can mean 

the person is physically and mentally well enough 

to perform their role. Secondly, it can mean 

that the person is of good character, as they are 

honest, reliable and trustworthy, and that they 

have the right skills, qualifications and experience 

to perform their role. 

For clarity and consistency in the outcomes 

and prompts, we use the following terms and 

meanings only: 

Fit: this means that the person is of good 

character, as they are honest, reliable and 

trustworthy, and that they have the right 

skills, qualifications and experience to perform 

their role. 

Physically and mentally able: this means that 

the person is physically and mentally well enough 

to perform their role taking into account any 

reasonable adjustments that may be necessary 

and the development of plans of support to 

enable them to undertake their work. 


Clinical governance 

Providers of healthcare services will be familiar 

with the term ‘clinical governance’. It does not 

relate to providers of social care services. 

We have not specifically described what a 

system of clinical governance should look like 

in this guide, as clinical governance has several 

purposes beyond simply establishing the essential 

standards of quality and safety. However, it 

is important for providers of healthcare to 

have a strong system of clinical governance in 

place. While the guide as a whole supports the 

development of an effective clinical governance 

system, we believe that the outcomes and 

prompts for the following outcomes are of 

particular importance: 

l● Outcome 1: Respecting and involving people 

who use services 

l● Outcome 2: Consent to care and treatment 

l● Outcome 4: Care and welfare of people who 

use services 

l● Outcome 6: Cooperating with other providers 

l● Outcome 7: Safeguarding people who use 

services from abuse 

l● Outcome 8: Cleanliness and infection control 

l● Outcome 9: Management of medicines 

l● Outcome 10: Safety and suitability of premises 

l● Outcome 11: Safety, availability and suitability 

of equipment 


l● Outcome 12: Requirements relating to workers 

l● Outcome 14: Supporting workers 

l● Outcome 16: Assessing and monitoring the 

quality of service provision 

l● Outcome 17: Complaints 

l● Outcome 21: Records. 


37


Checklist before reading the 

guidance in part 2 

You are about to start reading the detailed elements of the guidance. 

Before you do this, check the following: 

Have you read Step 1? 

This will give you a general understanding of the legislation and 

the framework of regulation, and how this guidance links to it. 

Have you selected your service types in Step 2? 

This is important as, without it, you will not be able to 

decide which prompts are relevant to you. 

Have you understood the definitions explained in Step 3? 

This is important as, without doing this, you may not fully 

understand the outcomes and prompts and how you need to 

interpret them. 

Need help? 

For general help and support, or to clarify elements of the guidance, 

you can: 

l● Look at our website: www.cqc.org.uk 

l● Speak to your local assessment team or relationship manager 

l● Contact our customer services team on 03000 616161 

l● Email us at enquiries@cqc.org.uk 

● 

l Write to us at: 

Care Quality Commission, National Correspondence, 

Citygate, Gallowgate, Newcastle upon Tyne NE1 4PA. 



Our guidance about compliance with the Health and Social 

Care Act 2008 (Regulated Activities) Regulations 2010 and the 

Care Quality Commission (Registration) Regulations 2009. 

➜ 

Care Quality Commission: Guidance Care about Quality compliance Commission: Essential A quality standards service, of a quality and experience safety – March Guidance 2010 39





This section looks at what providers should do to make sure that people 

who use services, or those acting on their behalf, are involved in making 

decisions about their care, treatment and support. It identifies what 

providers should do to ensure that the views and experiences of people 

who use services are taken into account when making decisions about 

how services are delivered and improved in order to meet the registration 

regulations. 

It also looks at the information that providers should make available to 

people so that they are able to make informed choices, including 

information about any charges they are expected to pay for their care, 

treatment and support. 

This section covers guidance about compliance for: 

1. Respecting and involving people who use services 

2. Consent to care and treatment 

3. Fees. 


41


Outcome 1: Respecting and involving 

people who use services 

Regulation 

➜ 

What do the regulations say? 

Respecting and involving service users 

17.—(1) The registered person must, so far as reasonably practicable, 

make suitable arrangements to ensure— 

(a) the dignity, privacy and independence of service users; and 

(b) that service users are enabled to make, or participate in making, 

decisions relating to their care or treatment. 

(2) For the purposes of paragraph (1), the registered person must— 

(a) treat service users with consideration and respect; 

(b) provide service users with appropriate information and support in 

relation to their care or treatment; 

(c) encourage service users, or those acting on their behalf, to— 

(i) understand the care or treatment choices available to the service 

user, and discuss with an appropriate health care professional, or 

other appropriate person, the balance of risks and benefits 

involved in any particular course of care or treatment, and 

(ii) express their views as to what is important to them in relation 

to the care or treatment; 

(d) where necessary, assist service users, or those acting on their behalf, 

to express the views referred to in sub-paragraph (c)(ii) and, so far as 

appropriate and reasonably practicable, accommodate those views; 

(e) where appropriate, provide opportunities for service users to manage 

their own care or treatment; 

(f) where appropriate, involve service users in decisions relating to the 

way in which the regulated activity is carried on in so far as it relates 

to their care or treatment; 

(g) provide appropriate opportunities, encouragement and support to 

service users in relation to promoting their autonomy, independence 

and community involvement; and 

(h) take care to ensure that care and treatment is provided to service 

users with due regard to their age, sex, religious persuasion, sexual 

orientation, racial origin, cultural and linguistic background and any 

disability they may have. 

Regulation 17 of the Health and Social Care Act 2008 (Regulated 

Activities) Regulations 2010 


Outcome 

➜ 


What should people who use services 

experience? 

People who use services: 

●● Understand the care, treatment and support choices available to 

them. 

●● Can express their views, so far as they are able to do so, and are 

involved in making decisions about their care, treatment and support. 

●● Have their privacy, dignity and independence respected. 

●● Have their views and experiences taken into account in the way the 

service is provided and delivered. 

Those acting on behalf of people who use services: 

●● Understand the care, treatment and support choices available to the 

people who use services. 

●● Can represent the views of the person using the service by expressing 

these on their behalf, and are involved appropriately in making 

decisions about their care, treatment and support. 

This is because providers who comply with the regulations will: 

●● Recognise the diversity, values and human rights of people who use 

services. 

●● Uphold and maintain the privacy, dignity and independence of people 

who use services. 

●● Put people who use services at the centre of their care, treatment and 

support by enabling them to make decisions. 

●● Provide information that supports people who use services, or others 

acting on their behalf, to make decisions about their care, treatment 

and support. 

●● Support people who use services, or others acting on their behalf, to 

understand the care, treatment and support provided. 

●● Enable people who use services to care for themselves where this is 

possible. 

●● Encourage and enable people who use services to be involved in how 

the service is run. 

●● Encourage and enable people who use services to be an active part of 

their community in appropriate settings. 


43 

1


Prompts 

➜ 

1A 

Prompts for all providers to consider 

Ensure personalised care, treatment and support through 

involvement 

People who use services are involved in and receive care, treatment and 

support that respects their right to make or influence decisions because 

the service: 

●● Explains and discusses their care, treatment and support options with 

them. 

●● Respects their right to take informed risks, while balancing the need for 

preference and choice with safety and effectiveness. 

●● Promotes and respects their privacy, dignity, independence and human 

rights by: 

– placing the needs, wishes, preferences and decisions of people who use 

services at the centre of assessment, planning and delivery of care, 

treatment and support 

– ensuring that the environment allows privacy in which the intimate care, 

treatment and support needs of the person who uses services are met 

– having clear procedures followed in practice, monitored and reviewed 

that ensure staff understand the concepts of privacy, dignity, 

independence and human rights and how they should be applied to the 

people who use the service 

– ensuring that the need to maintain confidentiality or disclose information 

is taken account of in the assessment of the individual circumstances 

– actively listening to and involving people who use services, or others 

acting on their behalf, in decision making. 

●● Provides information to help people who use services, or others acting on 

their behalf, to understand their care, treatment and support, including the 

risks and benefits, and their rights to make decisions. 

●● Ensures that staff recognise and respect the diversity and human rights of 


●● Makes people who use services aware of independent advocacy services 

wherever they are available. 

● 

● Cooperates with independent advocacy services wherever a person who 

uses services uses one. 


1B 

1C 


People who use services have their care, treatment and support needs 

met because: 

●● They are listened to. 

●● They, or those acting on their behalf, are involved in assessing, planning 

and carrying out their care, treatment and support. 

●● The things that are important to them in relation to their care, treatment 

and support are established as part of the assessment, and the support to 

meet these needs is provided. 

●● Staff are respectful of the decisions made by people who use services. 

Manage risk through effective procedures about 

involvement 

People who use services receive care, treatment and support where clear 

procedures are followed in practice, monitored and reviewed. These 

procedures ensure that: 

●● Care, treatment and support options, and the risks and benefits of those 

options, are explained. 

●● Choices and preference of the person who uses the service are expressed 

by them or others acting on their behalf. 

●● The choices of people who use services are respected and accommodated 

unless: 

– the choice places other people at risk of harm or injury 

– it would not be reasonable to expect the service to have the resources 

needed to achieve the choice 

– it is not within the provider’s stated aims, objectives and purpose to 

meet the choice 

– the person who uses the service does not have capacity to make that 

decision 

– the person who uses the service is subject to a legal restriction that 

prohibits them making a choice. 

●● Individualised assessments and plans of care, treatment and support are 

based on their needs, choices and preferences. 

●● Arrangements are in place for someone to act on the behalf of the person 

using the service, where the person who uses services agrees to it or it is 

legally authorised or required. 

● 

● Any reasonable adjustments are made so that the person who uses services 

is enabled to be involved in decision making. 


45 

1


1D 

1E 

1F 

People who use services benefit from a service that: 

●● Takes into account relevant guidance, including that from the Care Quality 

Commission’s Schedule of Applicable Publications (see appendix B). 

Promote rights and choices 

People who use services, or others acting on their behalf, are supported 

to make informed choices about their care, treatment and support 

because they are: 

●● Given the information they need to make choices. 

●● Are able to discuss the options available to them with a person who: 

– understands their individual needs, choices and preferences 

– knows what the aims and limitations of the service are 

– understands the various choices that the person who uses the service 

could make 

– is aware of the consequences of the various choices that the person who 

uses the service could make 

– is able to present the risks and benefits of the options based on 

evidence, research or experience. 

●● Given the time they need to make their decision, taking account of the 

urgency of the situation. 

●● Given relevant information to encourage them to change lifestyle 

behaviours that are placing their health at risk, so they can make informed 

choices about whether they wish to lead a healthier life. 

People who use services receive care, treatment and support that is 

provided in a way that ensures their independence is promoted by: 

●● Involving them, as far as is possible, in their needs assessment, planning 

and setting care, treatment and support goals. 

●● Respecting their choice to care for themselves or manage their own 

treatment, wherever they can. 

● 

● Enabling people who use services, or others acting on their behalf, to make 

informed choices even where there are risks involved with the decision they 

make. 


1G 

1H 

1I 

1J 



provided in a way that ensures their human rights and diversity are 

respected by: 

●● Discussing information about choices in a way they can understand. 

●● Providing information about what their rights are. 

●● Having staff who are aware of, understand and recognise the person’s 

social and cultural diversity, values and beliefs that may influence their 

decisions and how they want to receive care, treatment and support. 

People who use services are provided with information about: 

●● The aims, objectives and purpose of the service. 

●● The facilities that are available for their care, treatment and support. 

●● How their care, treatment and support is reviewed. 

●● The cost of the services, where charges are applied. 

●● How to raise a concern or complaint about the service, and how it will be 

dealt with. 

●● Local advocacy services. 

People who use services, or others acting on their behalf, are given 

encouragement, support and opportunities to: 

●● Describe their holistic needs and to discuss the impact of their care, 

treatment and support on the person who uses the service. 

●● Raise specific needs or to express concerns relating to equality, diversity 

and human rights. 

People who use services can influence how the service is run as they are 

given opportunities to take part in decision making through: 

●● General discussions with the provider, on an informal basis, as the person 

who uses services wishes. 

●● Periodic surveys or gathering of their views. 

●● A representative user group made up of people who are using, or have 

used, the service or similar services. 

●● The cooperation with local involvement networks, where they have the 

right to enter and view the service. 

●● The cooperation with any other relevant user forums. 


47 

1


1K 

1L 

Additional prompts for specific service types 

In addition to the prompts for all providers above, the following prompts 

relate to specific service types. Please refer to “Step 2: Select your service 

types” on page 13, to make sure that you identify which service types apply 

to you. 

People who use services can be confident that: 

●● The outcome of diagnostic tests and assessments will be explained and 

discussed with them in a way which they are able to understand and which 

enables them to make informed choices about their care, treatment and 

support, where this is the role or responsibility of the service undertaking 

the test. 

This guidance applies to the service types ticked below: 

ACS ✔ AMB ✔ BTS CHC ✔ CHN CHS DCC 

DCS ✔ DEN ✔ DSS ✔ DTS ✔ EXC HBC HPS ✔ 

LDC ✔ LTC ✔ MBS ✔ MHC ✔ MLS ✔ PHS ✔ RCA ✔ 

RHS ✔ RSM SHL SLS SMC SPC UCS ✔ 

People using rehabilitation or treatment services for substance misuse 

can be confident that: 

●● There will be restrictions placed on them when using the service, in line 

with the service’s treatment approach, which may include limitations to: 

– flexibility in daily routines and freedom 

– privacy 

– choices 

– access to facilities 

– personal relationships. 

●● Where there are restrictions placed on them, they are: 

– based on specialist need and risk assessment, or required by their 

treatment programme 

– agreed with them during assessment 

– reviewed as they progress through their treatment programme 

– proportionate and in line with human rights legislation. 


1M 





LDC LTC MBS MHC MLS ✔ PHS RCA 

RHS RSM ✔ SHL SLS SMC ✔ SPC UCS 

People who use services are enabled to: 

●● Participate in the activities of the local community so that they can exercise 

their right to be a citizen as independently as they are able to. 


ACS AMB BTS CHC CHN ✔ CHS ✔ DCC ✔ 

DCS DEN DSS DTS EXC ✔ HBC HPS 

LDC ✔ LTC ✔ MBS MHC ✔ MLS ✔ PHS RCA 

RHS ✔ RSM SHL ✔ SLS ✔ SMC ✔ SPC UCS 


49 

1


Outcome 2: Consent to care and 

treatment 

Regulation 

➜ 

Outcome 

➜ 


Consent to care and treatment 

18. The registered person must have suitable arrangements in place for 

obtaining, and acting in accordance with, the consent of service users in 

relation to the care and treatment provided for them. 




experience? 


●● Where they are able, give valid consent to the examination, care, 

treatment and support they receive. 

●● Understand and know how to change any decisions about 

examination, care, treatment and support that has been previously 

agreed. 

●● Can be confident that their human rights are respected and taken into 

account. 


●● Have systems in place to gain and review consent from people who 

use services, and act on them. 


Prompts 

➜ 

2A 



Manage risk through effective consent procedures 

Where they are able, people who use services receive the examination, 

care, treatment and support they agree to. This is because clear 

procedures to get valid consent are followed in practice, monitored and 

reviewed. Wherever consent is required these procedures include: 

●● Ensuring that consent is sought by a person who has sufficient knowledge 

about the person who uses the service, and the care, treatment and 

support options they are considering in order that the person who uses the 

service can make an informed decision. 

●● Ensuring that the risks, benefits and alternative options are discussed and 

explained in a way that the person who uses the service is able to 

understand. 

●● Ensuring where the person using the service lacks capacity, best interest 

meetings are held with people who know and understand the person using 

the service. 

●● Ensuring people who use services are given enough time to think about 

their consent decisions where requested, except in an emergency when this 

may not always be possible. 

●● Respecting confidentiality whenever this is requested by a child who is 

competent to make their own decision. 

●● The identification of who has parental responsibility in circumstances where 

a child is unable to give consent. 

●● The arrangements for seeking and obtaining consent for children. 

●● Respecting the right of people who use services to have an advocate to 

assist them in understanding their options and enable them to make an 

informed decision. 

●● Where treatment is refused, explaining the risks and benefits of refusing 

and the alternative options. 

●● Respecting and taking account of a decision by the person who uses the 

service to refuse or withdraw consent. 

● 

● Following any advance decision made in line with the Mental Capacity Act 

2005 that the person using the service may have made, wherever this is 

known by the provider. 


51 

2


2B 

●● The arrangements for taking account of restrictions authorised under the 

deprivation of liberty safeguards. 

●● The regular review of consent decisions taking into account the changing 

needs of the person who uses the service. 

●● Specific arrangements for seeking consent when a person is taking part in 

health and care-related research. 

People who use services benefit from staff who understand: 

●● The circumstances in which written consent must be taken. 

●● The way in which written consent must be documented. 

●● The circumstances in which verbal or implied consent can be taken. 

●● How to respect the cultural, social values and beliefs of the person who 

uses the service. 

●● That some people who use services may require more support than others 

in obtaining consent. 

●● How to identify when a person is not able to give valid consent at the time 

it is required. 

●● That sufficient details about the care, treatment and support options 

available should be provided in order for them to make an informed 

decision. 

●● That in a life threatening emergency situation, when receiving consent is 

not possible, decisions are made which are in the best interests of the 

person who uses the service. 

●● That consent is ongoing and can be withdrawn by the person who uses 

services at any time. 

●● How to respond to the decisions people who use services make about their 

care, treatment and support including: 

– respecting decisions even when they disagree 

– what to do when the wishes of the person who uses the service conflict 

with their care, welfare and safety needs 

– what to do when the wishes of the person who uses the service conflict 

with those of any other person acting on their behalf 

– how to respond to advance decisions 

– how to act so that valid consent is obtained for children while respecting 

their human rights and confidentiality. 


2C 

2D 

2E 

2F 


There are clear procedures that are followed in practice, monitored and 

reviewed about decision making for people who are unable to give, or 

choose to withhold, consent for each individual care, treatment and 

support activity, including: 

●● Meeting the requirements of the Mental Health Act 1983, the Mental 

Capacity Act 2005 and the Children Act 1989. 

●● Staff knowing the circumstances in which an advance directive or advance 

decision regarding the refusal of treatment by a person using services may 

be lawfully over-ruled. 

●● Where a life threatening emergency may arise and it is not possible to 

obtain consent. 




People are able to make a decision about whether or not to give consent 

because: 

●● They have information about the alternative options for their care, 

treatment and support and the risks and benefits of each. 





to you. 

People who use services give valid consent because: 

●● Arrangements are followed to ensure that cosmetic surgery does not take 

place on the same day as the consultation. 


ACS ✔ AMB BTS CHC CHN CHS DCC 

DCS ✔ DEN DSS DTS ✔ EXC HBC HPS 

LDC LTC MBS ✔ MHC MLS PHS RCA 



53 

2


2G 

People who use imaging services who do not have symptoms indicating 

that imaging is required must: 

●● Receive information regarding the risks and benefits prior to the procedure 

being carried out including: 

– risks directly associated with the procedure 

– risks associated with unclear or incorrect results. 



DCS ✔ DEN DSS ✔ DTS ✔ EXC HBC HPS 




2H 

People who use services are supported to: 


●● Make a decision about whether or not to give consent when this is not in 

conflict with any restrictions set by the courts, Mental Health Act 1983, 

Mental Capacity Act 2005 or criminal justice system. 




LDC ✔ LTC MBS MHC ✔ MLS ✔ PHS ✔ RCA 



55 

2



Regulation 

➜ 


Fees etc. 

19.—(1) Where a service user will be responsible for paying the costs of 

their care or treatment (either in full or partially), the registered person 

must provide a statement to the service user, or to a person acting on 

the service user’s behalf— 

(a) specifying the terms and conditions in respect of the services to be 

provided to the service user, including as to the amount and method 

of payment of fees; and 

(b) including, where applicable, the form of contract for the provision of 

services by the service provider. 

(2) The statement referred to in paragraph (1) must be— 

(a) in writing; and 

(b) as far as reasonably practicable, provided prior to the 

commencement of the services to which the statement relates. 

Regulation 19 of the Care Quality Commission (Registration) 



Outcome 

Prompts 

➜ What should people who use services 

experience? 

➜ 

3A 


People who use services, or others acting on their behalf, who 

pay the provider for the services they receive: 

●● Know how much they are expected to pay, when and how. 

●● Know what the service will provide for the fee paid. 

●● Understand their obligations and responsibilities. 


●● Be transparent in the information they provide about any fees, 

contracts and terms and conditions, where people are paying either in 

full or in part for the cost of their care, treatment and support. 


The following prompts relate to all registered providers wherever the person 

using the service personally pays the provider for any part of their care, 

treatment and support, as part of a private or joint funding arrangement of 

any kind or a private medical insurance policy. 

Manage risk through effective procedures about financial 

agreements 

People who use services, or others acting on their behalf, who pay the 

provider in full for their care, treatment and support either from private 

means, money received as a grant, benefit, or an insurance scheme, in 

order to purchase it: 

●● Are made aware of the requirement for them to pay for their care, 

treatment and support and the expected costs. 

●● Are given the time they need to consider whether they wish to proceed 

with the care, treatment and support. 

●● Are not placed under undue pressure to agree to sign an agreement. 

●● Receive a copy of the agreement they will enter into if they decide to 

proceed with the care, treatment and support and are given time to 

consider whether they wish to proceed with it in line with applicable 

consumer regulations. 


57 

3


3B 

3C 

3D 

●● Are given a statement of their account at any time they request it. 

●● Are given terms and conditions that clarify the actions that will be taken in 

the event of non payment and/or late payment of fees. 

●● Receive a final copy of any agreement they sign. 

●● Are offered a receipt for money they pay to the service. 

People who use services whose care, treatment and support funding is 

paid to the service provider by a third party purchaser, but where the 

person or others acting on their behalf makes a contribution to the 

provider from their own private means: 

●● Are offered a receipt for money they pay to the service. 

People who use services who enter into a separate arrangement with 

a service provider because they choose to pay for additional care, 

treatment and support which is not contracted on their behalf by a third 

party purchaser: 

●● Have the additional services they purchase arranged so that they: 

– are made aware of the requirement for them to pay for their care, 

treatment and support and the expected costs 

– are given the time they need to consider whether they wish to proceed 

with the care, treatment and support 

– are not placed under undue pressure to agree to sign an agreement 

– receive a copy of the agreement they will enter into if they decide to 

proceed with the care, treatment and support 

– receive a final copy of any agreement they sign 

– are offered a receipt for money they pay to the service 

– are given a statement of their account at any time they request it, and 

when the account is fully paid. 


● 

● Takes into account relevant guidance, including that from the Care Quality 



3E 

3F 



People who use services who pay the provider in full for their care, 

treatment and support and people who use services who enter into 

a separate arrangement with a service provider because they choose 

to pay for care, treatment and support that is not contracted on their 

behalf by a third party purchaser: 

●● Are able to discuss the terms of the agreement with someone who knows 

enough about it to be able to answer any questions they have, so that they 

can decide if they wish to proceed. 

●● Can make decisions about the costs and terms because information is given 

about these. 

●● Know when they or the service can cancel the agreement. 

●● Are told what the fee is and what it covers. 

●● Are given an estimate of how much it will cost if a fixed price cannot be 

given. 

●● Are told of any likely costs in addition to the price or estimate quoted. 

●● Are told when any unexpected additional costs need to be made, before 

the care, treatment and support that will lead to those additional costs is 

provided, wherever this is possible. 

●● Are notified of any planned increases in ongoing fees with sufficient time 

that they can consider whether they wish to continue with that service. 

●● Are told when payments are due and are given reasonable notice of these 

dates so that they have the opportunity to arrange payment without 

incurring a penalty of any sort, and to ensure they do not build up debt. 

●● Are told about how they can make payments and the payment process. 

People who use services whose care, treatment and support funding is 

paid to the service provider by a third party purchaser, but where the 

person makes a contribution from their own private means and which is 

collected by the provider on behalf of a third party purchaser: 

●● Are told what the fee is. 

●● Are told when payments are due and are given reasonable notice of these 

dates so that they have the opportunity to arrange payment without 

incurring a penalty of any sort. 

●● Are told about how they can make payments and the payment process. 


59 

3


3G 





to you. 

People who use services who pay the provider in full for their care, 

treatment and support: 

●● Are told that they may become eligible for local authority social care 

funding support when their capital or income drops to the Government set 

threshold. 







Personalised care, treatment 

and support 

Personalised care, treatment and support 


who use services get effective, safe and appropriate care, treatment and 

support that meets their individual needs. 


4. Care and welfare of people who use services 

5. Meeting nutritional needs 

6. Cooperating with other providers. 


61


Outcome 4: Care and welfare of people 

who use services 

Regulation 

➜ 


Care and welfare of service users 

9.—(1) The registered person must take proper steps to ensure that 

each service user is protected against the risks of receiving care or 

treatment that is inappropriate or unsafe, by means of— 

(a) the carrying out of an assessment of the needs of the service user; 

and 

(b) the planning and delivery of care and, where appropriate, treatment 

in such a way as to— 

(i) meet the service user’s individual needs, 

(ii) ensure the welfare and safety of the service user, 

(iii) reflect, where appropriate, published research evidence and 

guidance issued by the appropriate professional and expert 

bodies as to good practice in relation to such care and treatment, 


(iv) avoid unlawful discrimination including, where applicable, by 

providing for the making of reasonable adjustments in service 

provision to meet the service user’s individual needs. 

(2) The registered person must have procedures in place for dealing with 

emergencies which are reasonably expected to arise from time to time 

and which would, if they arose, affect, or be likely to affect, the 

provision of services, in order to mitigate the risks arising from such 

emergencies to service users. 




Outcome 

Prompts 

➜ 

➜ 

4A 



experience? 


●● Experience effective, safe and appropriate care, treatment and support 

that meets their needs and protects their rights. 


●● Reduce the risk of people receiving unsafe or inappropriate care, 

treatment and support by: 

– assessing the needs of people who use services 

– planning and delivering care, treatment and support so that people 

are safe, their welfare is protected and their needs are met 

– taking account of published research and guidance 

– making reasonable adjustments to reflect people’s needs, values 

and diversity 

– having arrangements for dealing with foreseeable emergencies. 


Ensure effective, safe and appropriate, personalised care, 

treatment and support through coordinated assessment, 

planning and delivery 

People who use services have safe and appropriate care, treatment and 

support because their individual needs are established from when they 

are referred or begin to use the service. The assessment, planning and 

delivery of their care, treatment and support: 

●● Is centred on them as an individual and considers all aspects of their 

individual circumstances, and their immediate and longer-term needs. 

●● Is developed with them, and/or those acting on their behalf. 

●● Reflects their needs, preferences and diversity. 

●● Identifies risks, and says how these will be managed and reviewed. 

●● Ensures that risk assessments balance safety and effectiveness with the 

right of the person who uses the service to make choices, taking account of 

their capacity to make those choices and their right to take informed risks. 


63 

4


4B 

●● Ensures that plans of care, treatment and support are implemented, 

flexible, regularly reviewed for their effectiveness, changed if found to be 

ineffective and kept up to date in recognition of the changing needs of the 

person using the service. 

●● Maintains their welfare and promotes their wellbeing by taking account of 

all their needs, including: 

– physical 

– mental 

– social 

– personal relationships 

– emotional 

– daytime activity. 

●● Ensures continuity in their care, treatment and support as a result of 

effective communication between all of those who provide it, including 

other providers. 

●● Enables people to maintain, return to, or manage changes to their health or 

social circumstances. 

●● Is undertaken to reduce the risk of deterioration in their health status. 

●● Encourages the prevention and early detection of ill health, including 

relapse, wherever there are real factors that present a risk to their health 

and welfare. 

●● Enables them to make healthy living choices concerning exercise, diet and 

lifestyle. 

Manage risk through effective procedures 


●● Reflects on the findings of their service reviews. 

●● Learns from adverse events, incidents, errors and near misses that have 

occurred within the service so that the risk of these being repeated is 

reduced to a minimum. 

●● Informs them, or others acting on their behalf, if an adverse event, incident 

or error has occurred in their care, treatment or support that has caused, or 

may result in, harm and offers a full explanation of what happened along 

with an appropriate apology or expression of regret. 

● 

● Implements and acts upon the recommendations of safety and risk alerts 

and notices. 


4C 

4D 

4E 


●● Makes plans in advance of a foreseeable emergency, to ensure the needs of 

people who use the services will continue to be met before, during and 

after the emergency. These plans include: 

– defined roles and accountabilities 

– contingency arrangements to respond to additional demands while 

maintaining the essential standards of quality and safety. 


Commission’s Schedule of Applicable Publications (see appendix B), and 

any other good practice guidance which relates to the care, treatment and 

support provided by the service and which is published by a professional or 

expert body that is relevant. 


●● Wherever possible, they will know the names and job titles of the people 

who provide their care, treatment and support and how to contact them. 

●● They have adequate plans in place for when they leave the service and are 

fully involved in this planning, where they have capacity and the wish to 

do so. 


●● Staff will quickly recognise when a person who uses services becomes 

seriously ill, physically and/or mentally, and requires treatment, and 

immediately respond to meet their needs. 

●● In these circumstances staff will ensure that where the person who uses 

services needs to be transferred to another service, or within the service, 

this is done as quickly and safely as possible. 



●● Are involved in identifying their care, treatment and support options and 

the alternatives, risks and benefits of each are explained. 

●● Are supported to make informed decisions where they are unable to do this 

by themselves. 

●● Have sufficient information to enable them, or a person acting on their 

behalf, to make informed choices and decisions about the service. 


65 

4


4F 

4G 

4H 





to you. 

People who use services know that: 

●● They will receive care, treatment and support in single sex accommodation 

wherever it is available. 



DCS DEN DSS DTS EXC HBC HPS ✔ 



People who use services know that: 

●● Their length of stay will be as short as possible in order to meet their 

needs, or as required by legal restrictions. 

●● Their accommodation will not limit their freedom any further than is agreed 

in their plan of care. 







●● Analysis of diagnostic tests and assessments are undertaken by qualified 

staff in a way which follows guidelines from relevant expert and 

professional bodies. 

● 

● Where the provider uses telemedicine diagnostic services from outside 

England those services meet the same standards as they would have had 

they been located in England and subject to registration under the Health 

and Social Care Act 2008. 


4I 

4J 



ACS ✔ AMB ✔ BTS CHC ✔ CHN CHS DCC 


LDC LTC ✔ MBS ✔ MHC ✔ MLS ✔ PHS ✔ RCA ✔ 

RHS ✔ RSM ✔ SHL SLS SMC ✔ SPC UCS ✔ 

Children who use services are: 

●● Fully informed of their care, treatment and support. 

●● Able to take part in decision making to the fullest extent that is possible. 

●● Asked if they agree for their parents or guardians to be involved in 

decisions they need to make. 

●● Able to benefit from an environment that is appropriate to their age and 

individual needs. 


ACS ✔ AMB ✔ BTS CHC ✔ CHN CHS DCC ✔ 


LDC LTC ✔ MBS ✔ MHC ✔ MLS ✔ PHS ✔ RCA ✔ 

RHS RSM SHL SLS SMC SPC UCS ✔ 

Women undergoing a termination of pregnancy know that: 

●● The correct referral procedures are followed by a medical practitioner or 

approved pregnancy advice bureau. 

●● A 24-hour telephone advice is available to provide support after they leave 

the service. 

●● They are able to express their preferences for the disposal of foetal tissue. 

●● They are able to discuss their choices and decisions with a trained 

counsellor. 

●● Where services are provided to children or people with a learning disability, 

the counsellor available has relevant expertise in discussing termination of 

pregnancy with them. 


67 

4


4K 



DCS DEN DSS DTS ✔ EXC HBC HPS 



People who use services who are at the end of their life will have their 

care, treatment and support needs met because, wherever possible: 

●● They are involved in the assessment and planning for their end of life care 

and are able to make choices and decisions about their preferred options, 

particularly those relating to pain management. 

●● There are systems in place to ensure further assessments by specialist 

palliative care services and other specialists, where needed. 

●● They have information relating to death and dying available to them, their 

families or those close to them. 

●● There are arrangements to minimise unnecessary disruption to the care, 

treatment, support and accommodation of the person who uses the 

service, their family and those close to them. 

●● They are able to have those people who are important to them, with them 

at the end of their life. 

●● They have a dignified death, because staff are respectful of their needs for 

privacy, dignity and comfort. 

●● The plan of care records their wishes with regards to how their body and 

possessions are handled after their death and staff respect their values and 

beliefs. 


ACS ✔ AMB BTS CHC ✔ CHN ✔ CHS ✔ DCC ✔ 

DCS DEN DSS DTS EXC ✔ HBC HPS ✔ 

LDC ✔ LTC ✔ MBS MHC MLS ✔ PHS RCA 

RHS RSM ✔ SHL ✔ SLS ✔ SMC SPC ✔ UCS ✔ 


4L 

4M 


People who use services who are thought to present a risk of suicide 

and homicide or harm to themselves or others have an ongoing, 

multi‑disciplinary assessment and plan of care made: 

●● To determine whether they have a history of harm to themselves or others. 

●● To establish any risk of suicide and homicide or harm to themselves or 

others, including environmental risks, and how these can be minimised. 







●● Ensures that patient safety alerts, rapid response reports and patient safety 

recommendations issued by the National Patient Safety Agency (NPSA) 

and which require action are acted upon within required timescales. 


ACS ✔ AMB ✔ BTS ✔ CHC ✔ CHN ✔ CHS ✔ DCC ✔ 

DCS ✔ DEN ✔ DSS ✔ DTS ✔ EXC HBC ✔ HPS ✔ 


RHS ✔ RSM ✔ SHL SLS ✔ SMC ✔ SPC ✔ UCS ✔ 


69 

4


4N 

4O 


have: 

●● Their care, treatment and support options explained before they start to 

use the service. These include any restrictions identified, and the 

alternatives, risks and benefits. 

●● A risk assessment completed that includes the risk of drug-related death. 


benefit from clear procedures followed in practice, monitored and 

reviewed, for when they leave the service, in a planned or unplanned 

way, that specify: 

●● Informing the referrer. 

●● An assessment of the risks associated with either planned or unplanned 

discharge which includes: 

– provision of harm reduction advice 

– assessment of the risk of overdose 

– informing services and those acting on their behalf if the person poses a 

risk to themselves or others 

– informing services locally if the person is likely to stay and use services in 

the area. 

The guidance in 4N and 4O applies to the service types ticked below: 






4P 

4Q 


People with a learning disability who use services: 

●● Are supported to have a health action plan developed by their primary care 

trust. 


ACS AMB BTS CHC ✔ CHN ✔ CHS ✔ DCC 


LDC ✔ LTC ✔ MBS MHC MLS ✔ PHS ✔ RCA 

RHS RSM ✔ SHL ✔ SLS ✔ SMC SPC UCS 

People who use services are only put in to seclusion if it is: 

●● In line with the National Institute for Health and Clinical Excellence’s 

clinical guideline on Violence: the short term management of disturbed or 

violent behaviour in in-patient psychiatric settings and emergency 

departments (2005). 

●● Carried out following clear procedures that are monitored, reviewed and in 

line with the Mental Health Act 1983 Code of Practice. 

●● In an environment that complies with the Mental Health Act 1983 Code of 

Practice. 




LDC LTC ✔ MBS MHC MLS ✔ PHS ✔ RCA 



71 

4


4R 

4S 

People who use services have their needs met through the care 

programme approach: 

●● If they meet the criteria set out in Refocusing the Care Programme 

Approach: policy and positive practice guidance 2008. 


ACS ✔ AMB BTS CHC ✔ CHN ✔ CHS ✔ DCC ✔ 

DCS DEN DSS DTS EXC ✔ HBC HPS ✔ 

LDC ✔ LTC ✔ MBS MHC ✔ MLS ✔ PHS ✔ RCA 

RHS RSM ✔ SHL SLS ✔ SMC ✔ SPC UCS 

People who use services have care, treatment and support that: 

●● Follows clear procedures, that are monitored and reviewed and are 

prepared by a person who has sufficient experience of hyperbaric oxygen 

chambers, that describe: 

– the potential hazards of using a hyperbaric oxygen chamber 

– the potential hazards of using electrical devices in a hyperbaric oxygen 

chamber 

– how staff should work safely 

– the safety checks that must be completed for the preparation and use of 

the chamber and for anyone entering it 

– how the machine should be operated safely 

– how the staff should respond to an emergency situation 

– the treatment of level 1 or level 2 critical care patients, where the service 

treats such people. 

●● Is provided in a service that is under the direction of a medical practitioner 

with sufficient experience and expertise in the hyperbaric oxygen chamber 

treatments to ensure the risks of the treatment are minimised. 



DCS DEN DSS DTS EXC HBC ✔ HPS 




4T 

4U 



developed carefully and systematically where protocols or processes 

require rapid development in response to an unexpected public health 

event by ensuring that: 

●● There are clear procedures followed in practice, monitored and reviewed for 

the governance arrangements for this urgent development. 

●● There are advice protocols available that can be used as a starting point in 

readiness for such situations. 

●● The competency limits of staff who will be using the urgently developed 

protocols, and the points at which they will need to pass an individual case 

to a more experienced member of the team, are understood and fully 

considered when developing the protocol. 

●● The capacity of the service to manage the possible increase in demand as a 

result of the event is understood and fully considered when developing the 

protocol. 

●● People with the necessary skills and knowledge to safely develop the 

protocol are involved in the development, regardless of the time 

limitations. 

People who use services are supported by: 

●● Adequate arrangements to rapidly identify information submitted 

electronically or over the phone that suggests the person using the service 

may require emergency care, treatment or support. 

●● Such information, where it is identified, being passed to a more appropriate 

service, or practitioner within the same service, without delay so that the 

care, treatment and support the person using the service may need is 

provided as soon as possible. 

●● When first accessing the service, clear information is given to people 

accessing the service, including the type of support provided. 

●● Staff who understand what to do where: 

– a person in prison, detained under immigration restrictions or whose 

liberty is restricted under the Mental Health Act 1983 or the Mental 

Capacity Act 2005 contacts the service 

– another person contacts the service to discuss their needs. 


73 

4


4V 

The guidance in 4T and 4U applies to the service types ticked below: 



LDC LTC MBS MHC MLS PHS RCA ✔ 



●● Blood, blood products and human tissue donated for transplantation are 

only taken from donors who do not present an unacceptable risk to the 

person because of: 

– their previous medical history 

– their lifestyle 

– any medicines they may or may have previously taken 

– recent travel abroad 

– their age. 


ACS AMB BTS ✔ CHC CHN CHS DCC 





4W 

4X 



●● Are able to visit the service prior to using it so that they can decide 

whether or not they wish to use it, or to allow them to become familiar 

with it in order to allay anxiety or fear. This is made available wherever it is 

practical or appropriate to do so, and there is potential for the person who 

uses the service to substantially benefit from the visit. 


ACS ✔ AMB BTS CHC CHN ✔ CHS ✔ DCC 


LDC LTC ✔ MBS MHC MLS PHS RCA 

RHS RSM SHL ✔ SLS ✔ SMC SPC UCS 


●● Searches are conducted in line with nationally recommended practice. 

●● The service will prevent and rapidly respond to incidents of illicit drug use 

and supply on or near the premises. 




LDC LTC MBS MHC MLS ✔ PHS ✔ RCA 

RHS RSM ✔ SHL SLS SMC SPC UCS 


75 

4



Regulation 

➜ 


Meeting nutritional needs 

14.—(1) Where food and hydration are provided to service users as a 

component of the carrying on of the regulated activity, the registered 

person must ensure that service users are protected from the risks of 

inadequate nutrition and dehydration, by means of the provision of— 

(a) a choice of suitable and nutritious food and hydration, in sufficient 

quantities to meet service users’ needs; 

(b) food and hydration that meet any reasonable requirements arising 

from a service user’s religious or cultural background; and 

(c) support, where necessary, for the purposes of enabling service users 

to eat and drink sufficient amounts for their needs. 

(2) For the purposes of this regulation, “food and hydration” includes, 

where applicable, parenteral nutrition and the administration of dietary 

supplements where prescribed. 




Outcome 

Prompts 

➜ 

➜ 

5A 



experience? 


●● Are supported to have adequate nutrition and hydration. 


●● Reduce the risk of poor nutrition and dehydration by encouraging and 

supporting people to receive adequate nutrition and hydration. 

●● Provide choices of food and drink for people to meet their diverse 

needs, making sure the food and drink they provide is nutritionally 

balanced and supports their health. 


The following prompts relate to all registered providers where they prepare, 

or support people who use services to prepare, food and drink. The term 

‘provide’ means the preparation of food and drink and includes where the 

service gives support to people to eat and drink. The food and drink used may 

be purchased either by the provider or by the person using the service. These 

prompts do not cover the administration of artificial hydration which may be 

essential to maintain hydration. 

Ensure personalised care by providing adequate nutrition, 

hydration and support 

Where the service provides food and drink, people who use services 

have their care, treatment and support needs met because: 

●● Staff identify where the person who uses services is at risk of poor 

nutrition, dehydration or has swallowing difficulties, when they first begin 

to use the service and as their needs change. 

●● Action is taken where any risk of poor nutrition or dehydration is identified 

including any difficulty in swallowing or the impact of any medicines, and a 

referral is made to appropriate services. 

●● They know that their medical dietary and hydration requirements are 

identified and reviewed. 

●● Their plan of care includes how any identified risks will be managed. 

●● Relevant staff know what a balanced diet is. 

●● Staff involved in food preparation produce food to help facilitate a healthy, 

balanced diet. 


77 

5


5B 

●● They have food and drink that: 

– are handled, stored, prepared and delivered in a way that meets the 

requirements of the Food Safety Act 1990 

– are presented in an appetising way to encourage enjoyment 

– are provided in an environment that respects their dignity 

– meet the requirements of their diverse needs 

– take account of any dietary intolerances they may have. 

●● They can be confident that staff will support them to meet their eating and 

drinking needs with sensitivity and respect for their dignity and ability. 

●● They are enabled to eat their food and drink as independently as possible. 

●● All assistance necessary is provided to ensure they actually eat and drink, 

where they want to but are unable to do so independently. 

●● They have supportive equipment available to them that allows them to eat 

and drink independently, wherever needed. 

●● They are helped into an appropriate position that allows them to eat and 

drink safely, wherever needed. 

●● They are not interrupted during mealtimes unless they wish to be or an 

emergency situation arises. 

●● They will have any special diets or dietary supplements that their needs 

require arranged on the advice of an appropriately qualified or experienced 

person. 

●● They have access to specialist advice and techniques for receiving nutrition 

where their needs require it. 

●● The service takes into account relevant guidance, including that from the 

Care Quality Commission’s Schedule of Applicable Publications (see 

appendix B). 

Where the service provides food and drink, but not when this is in the 

person’s own home or Shared Lives arrangement, people have their care, 

treatment and support needs met because: 

●● A nutritional screening is carried out to identify where they are at risk of 

poor nutrition or dehydration when they first begin to use the service and 

at regular intervals. 

●● Where a full nutritional assessment is necessary because the nutritional 

screening identified risk of poor nutrition and dehydration, this is carried 

out by staff with the appropriate skills, qualifications and experience. 

● 

● They have their food and drink intake monitored when they are at risk of 

poor nutrition or dehydration and action is taken as necessary. 


5C 

5D 


●● They are not expected to wait for the next meal if their care, treatment and 

support means they missed a planned mealtime. 

●● The person can choose a balanced diet that is relevant to them as an 

individual, taking account of their nutritional status and previous wishes. 


Where the service provides food and drink, people who use services can 

make decisions about their food and drink because they: 

●● Have accessible information about meals and the arrangements for 

mealtimes. 

●● Have a choice for each meal that takes account of their individual 

preferences and needs, including their religious and cultural requirements. 

●● Have access to snacks and drinks throughout the day and night. 

●● Have mealtimes that are reasonably spaced and at appropriate times, 

taking account of reasonable requests including their religious or cultural 

requirements. 

●● Have information on what constitutes a balanced diet to help them make 

an informed decision about the type, and amount, of food they need to 

address any risk of poor nutrition and/or dehydration. 





to you. 

People who use services benefit from clear procedures followed in 

practice, monitored and reviewed to ensure they: 

●● Are only subject to fasting (for example before an operation or procedure) 

for the minimum possible period, and the service will ensure they have 

adequate hydration as soon as possible afterwards. Nutrition should be 

provided as soon as possible where facilities exist, or appropriate advice 

and opportunity is offered where those facilities do not exist. 

●● Can be confident that consideration is given to the duration of fasting for 

each person (including specific consideration for children) prior to the 

scheduling of operations or procedures. 

●● Are given nutrition as soon as possible after procedures requiring fasting 

are cancelled. 


79 

5


5E 

5F 


ACS ✔ AMB BTS CHC ✔ CHN CHS DCC 


LDC LTC ✔ MBS MHC MLS ✔ PHS ✔ RCA 



●● Have access to facilities for infant feeding, including facilities to support 

breastfeeding. 



DCS DEN DSS ✔ DTS EXC HBC HPS ✔ 


RHS RSM ✔ SHL SLS SMC SPC UCS ✔ 

People using rehabilitation or treatment services for substance misuse, 

where the service provides them with food and drink, will have some 

limited choice about: 

●● When to eat. 

●● Where to eat. 

●● Whether to eat alone, or with company. 







5G 

5H 

People who use services are: 


●● Actively supported to plan and prepare their own meals, where this is safe 

and they are able to do so. 


ACS AMB BTS CHC CHN CHS DCC ✔ 


LDC ✔ LTC MBS MHC MLS ✔ PHS RCA 

RHS RSM ✔ SHL ✔ SLS ✔ SMC SPC ✔ UCS 

People who use services are able to make choices about: 

●● What to eat. 

●● When to eat. 

●● Where to eat. 

●● Whether to eat alone, or with company. 


ACS AMB BTS CHC CHN ✔ CHS ✔ DCC 


LDC LTC ✔ MBS MHC ✔ MLS ✔ PHS ✔ RCA 

RHS RSM SHL SLS ✔ SMC SPC UCS 


81 

5


Outcome 6: Cooperating with other 

providers 

Regulation 

➜ 


Cooperating with other providers 

24.—(1) The registered person must make suitable arrangements to 

protect the health, welfare and safety of service users in circumstances 

where responsibility for the care and treatment of service users is shared 

with, or transferred to, others, by means of— 

(a) so far as reasonably practicable, working in cooperation with others 

to ensure that appropriate care planning takes place; 

(b) subject to paragraph (2), the sharing of appropriate information in 

relation to— 

(i) the admission, discharge and transfer of service users, and 

(ii) the co-ordination of emergency procedures; and 

(c) supporting service users, or persons acting on their behalf, to obtain 

appropriate health and social care support. 

(2) Nothing in this regulation shall require or permit any disclosure or 

use of information which is prohibited by or under any enactment, or by 

court order. 




Outcome 

Prompts 

➜ 

➜ 

6A 



experience? 


●● Receive safe and coordinated care, treatment and support where more 

than one provider is involved, or they are moved between services. 


●● Cooperate with others involved in the care, treatment and support of 

a person who uses services when the provider responsibility is shared 

or transferred to one or more services, individuals, teams or agencies. 

●● Share information in a confidential manner with all relevant services, 

individuals, teams or agencies to enable the care, treatment and 

support needs of people who uses services to be met. 

●● Work with other services, individuals, teams or agencies to respond to 

emergency situations. 

●● Support people who use services to access other health and social care 

services they need. 


The following prompts relate to all registered providers. For the purposes of 

this guidance, the term ‘individual’ includes carers or others acting on behalf 

of the person using the service. This is because the providers must cooperate 

on the provision of services with those other people as well as with other 

providers. 

Ensure personalised care through adequate coordination 

of services 

People who use services can be confident that when their care, 

treatment or support is provided by more than one service, team, 

individual or agency, or is transferred from one service, team, individual 

or agency to another, this is organised so that: 

●● A lead is always identified who is responsible for coordinating the care, 

treatment and support of the person who uses services. 

●● The person who uses services is aware of who the lead is and how to 

contact them. 

●● The plan of care includes arrangements for when a person who received 

care, treatment or support transfers between services. 


83 

6


6B 

●● Each of their assessed needs is met by the service, team, individual or 

agency that is accountable for doing so; ensuring, in total, that all those 

needs are met. 

●● All those involved in the care, treatment and support of the person who 

uses services: 

– cooperate with the planning and provision of care, treatment and 

support 

– have the documented plan of care available to them 

– have relevant information about the person who uses services available, 

where it has a direct bearing on the quality and safety of the care, 

treatment and support being delivered 

– record the key points of the care, treatment and support they have given 

– enable relevant information to be accessed in time to ensure that the 

needs of the person who uses services continue to be met. 

People who use services can be confident that when information about 

their care, treatment and support needs to be passed to another service, 

team, individual or agency, this is organised so that: 

●● The information includes everything the other service, individual, team or 

agency will need to ensure the needs of the person who uses services are 

met safely, even when the transfer of information is required urgently. As a 

minimum this includes: 

– their name 

– gender 

– date of birth 

– address 

– unique identification number where one exists 

– emergency contact details 

– any person(s) acting on behalf the person who uses services, with 

contact details if available 

– records of care, treatment and support provided up to the point of 

transfer 

– assessed needs 

– known preferences and any relevant diverse needs 

– previous medical history that is relevant to the person’s current needs, 

including general practitioner’s contact details 

– any infection that needs to be managed 

– any medicine they need to take 


6C 

6D 

– any allergies they have 


– key contact in the service the person is leaving 

– reason for transferring to the new service 

– any advance decision 

– any assessed risk of suicide and homicide and harm to self and others. 

●● The information is transferred in time to make sure that there is no delay to 

the assessment of needs by the other service, team, individual or agency. 

●● There are no interruptions to the continuity of care, treatment and support 

for the person who uses services. 

Lead effectively to manage risk 

People who use services can be confident that when more than one 

service, team, individual or agency is involved at the same time in their 

care, treatment and support, or are planned to be in the future, the 

services provided are organised so that: 

●● All those involved understand which service has the coordinating role and 

who is responsible for each element of care, treatment and support to be 

delivered. 

●● Each service, team, individual or agency is involved when the plan of care is 

reviewed or brought up to date. 

●● Where appropriate, all those involved discuss together the plan of care for 

the person who uses services. 

●● It takes into account relevant guidance, including that from the Care 

Quality Commission’s Schedule of Applicable Publications (see appendix B). 


●● Wherever it is required, has in place a planned and prepared response to 

major incident and emergency situations. This prepared response should 

include arrangements for sharing information with other providers, 

provision of mutual aid and arrangements for engagement with appropriate 

emergency planning and civil resilience partners across the local area. 

●● Is aware of and has arrangements in place to respond to any requirements 

made of the provider by the Civil Contingencies Act 2004. 

●● In partnership, practises, monitors and reviews all of the plans that are in 

place. 


85 

6


6E 


service, team, individual or agency is involved at the same time in their 

care, treatment and support or are planned to be in the future, the 

transfer of information is organised so that: 

●● The confidentiality of people who use services is protected. 

●● Information is transferred safely and securely. 

●● Where appropriate, the way in which information is documented, copied, 

stored and transferred to the other service has been agreed previously 

between the services, in line with laws that relate to the safe handling of 

information. 

●● Staff know the ways that are acceptable for transferring information. 

●● Information is transferred that: 

– is relevant to the continuing safe delivery of care, treatment and support 

– is factual, correct and does not include subjective opinions about the 

person 

– can be shared in line with the Data Protection Act 1998 and other 

relevant guidance. 

●● Staff notify their line manager if information has been lost or transferred 

incorrectly. 

●● There are clear procedures followed in practice, monitored and reviewed 

about the action to be taken when confidential information is 

inappropriately shared or stored or is lost. These procedures should include 

the requirement to inform the person who uses services if their information 

is transferred or shared inappropriately or lost. 

●● When information relates to a safeguarding allegation, or where disclosure 

is in the wider public interest for another reason, the disclosure is made in 

accordance with relevant legislation and guidance. As far as possible the 

consent of the person(s) whose information is to be disclosed should be 

obtained. 

● 

● Where the service cannot obtain consent, it is clear about the reasons and 

the necessity for sharing. 


6F 

6G 

6H 

6I 




service, team, individual or agency are involved at the same time in their 

care, treatment and support, or are planned to be in the future, the 

services provided are organised so that: 

●● The person who uses the service knows who to contact about their needs 

and if the needs are not being met. 

People who use services can be confident that when information about 

their care, treatment and support is, or needs to be, passed to another 

service, team, individual or agency, this is organised so that the person 

or others acting on their behalf: 

●● Are aware of the information about them that is being transferred. 

●● Can be provided with a copy of the information transferred if they want it. 

People who use services know that they: 

●● Can request information to be transferred to another service and that the 

service agrees to transfer the information requested unless there is a good 

reason why they cannot. If so, that reason is fully explained. 

People who use services are supported to access the care, treatment and 

support they need by a provider who: 

●● Makes them aware of other available health and social care services or 

support relevant to their care, treatment and support. 

●● Helps them to approach, or make a formal referral to, any other health and 

social care service or support they want to access, and that are relevant to 

their needs. 

●● Enables them, as far as possible, to access other health and social care 

services or support relevant to their care, treatment and support needs, 

provided that their care, treatment and support will not be compromised. 


87 

6


6J 

6K 

6L 





to you. 

People who use rehabilitation or treatment services for substance 

misuse who are provided with accommodation when they use the 

service: 

●● Are able to register with a general practitioner, dentist and any other health 

service they may require, as far as possible of their choice depending on 

the length of the treatment programme. 







●● Are able to register with a general practitioner, dentist and any other health 

service they may require, as far as possible of their choice. 





RHS RSM SHL ✔ SLS SMC SPC ✔ UCS 

People with mental health needs who use services: 

● 

● Are, where necessary, supported by local multi-agency public protection 

arrangements to protect themselves and others from harm. 


6M 

6N 





LDC ✔ LTC MBS MHC ✔ MLS ✔ PHS RCA 


When children who use services are moving to access adult services, 

these are organised so that: 

●● All those involved in the care, treatment and support cooperate with the 

planning and provision to ensure that the services provided continue to be 

appropriate to the age and needs of the person who uses services. 

●● Children and those acting on their behalf are involved in and informed 

about the move to adult care, treatment and support. 


ACS ✔ AMB BTS CHC ✔ CHN CHS DCC ✔ 

DCS ✔ DEN ✔ DSS DTS ✔ EXC HBC ✔ HPS ✔ 

LDC ✔ LTC ✔ MBS ✔ MHC ✔ MLS ✔ PHS ✔ RCA 

RHS ✔ RSM SHL SLS SMC ✔ SPC ✔ UCS 

People who use rehabilitation or treatment services for substance 

misuse will benefit from teams, individuals and/or agencies who: 

●● Assess at an early stage of their treatment, their need for services to 

support their reintegration into the wider community (including housing, 

employment, education and training services). 







89 

6






who use the service, workers and others who visit are as safe as they can 

be and that risks are managed. It looks at what the provider needs to do 

to ensure that the human rights and dignity of people who use services 

are respected and how they should identify and respond when people 

are in vulnerable situations. 

It also looks at the things providers should do to make sure that the 

premises and equipment they use to provide care, treatment and support 

are safe and suitable. 


7. Safeguarding people who use services from abuse 

8. Cleanliness and infection control 

9. Management of medicines 

10. Safety and suitability 

of premises 

11. Safety, availability and 

suitability of equipment. 


91


Outcome 7: Safeguarding people who use 

services from abuse 

Regulation 

➜ 


Safeguarding service users from abuse 


ensure that service users are safeguarded against the risk of abuse by 

means of— 

(a) taking reasonable steps to identify the possibility of abuse and 

prevent it before it occurs; and 

(b) responding appropriately to any allegation of abuse. 

(2) Where any form of control or restraint is used in the carrying on of 

the regulated activity, the registered person must have suitable 

arrangements in place to protect service users against the risk of such 

control or restraint being— 

(a) unlawful; or 

(b) otherwise excessive. 

(3) For the purposes of paragraph (1), “abuse”, in relation to a service 

user, means— 

(a) sexual abuse; 

(b) physical or psychological ill-treatment; 

(c) theft, misuse or misappropriation of money or property; or 

(d) neglect and acts of omission which cause harm or place at risk of 

harm. 




Outcome 

Prompts 

➜ 

➜ 

7A 



experience? 


●● Are protected from abuse, or the risk of abuse, and their human rights 

are respected and upheld. 


●● Take action to identify and prevent abuse from happening in a service. 

●● Respond appropriately when it is suspected that abuse has occurred or 

is at risk of occurring. 

●● Ensure that Government and local guidance about safeguarding 

people from abuse is accessible to all staff and put into practice. 

●● Make sure that the use of restraint is always appropriate, reasonable, 

proportionate and justifiable to that individual. 

●● Only use de-escalation or restraint in a way that respects dignity and 

protects human rights, and where possible respects the preferences of 


●● Understand how diversity, beliefs and values of people who use 

services may influence the identification, prevention and response to 

safeguarding concerns. 

●● Protect others from the negative effect of any behaviour by people 

who use services. 

●● Where applicable, only use Deprivation of Liberty Safeguards when it 

is in the best interests of the person who uses the service and in 

accordance with the Mental Capacity Act 2005. 


Lead effectively to reduce the potential of abuse 

People receive a service from a provider who takes steps to prevent 

abuse and does not tolerate any abusive practice should it occur. 

The provider minimises the risk and likelihood of abuse occurring by: 

●● Ensuring that staff and people who use services understand the aspects of 

the safeguarding processes that are relevant to them. 

●● Ensuring that staff understand the signs of abuse and raise this with the 

right person when those signs are noticed. 


93 

7


7B 

7C 

●● Ensuring that people who use services are aware of how to raise concerns 

of abuse. 

●● Having effective means to monitor and review incidents, concerns and 

complaints that have the potential to become an abuse or safeguarding 

concern. 

●● Having effective means of receiving and acting upon feedback from people 

who use services and any other person. 

●● Taking action immediately to ensure that any abuse identified is stopped 

and suspected abuse is addressed by: 

– having clear procedures followed in practice, monitored and reviewed 

that take account of relevant legislation and guidance for the 

management of alleged abuse 

– separating the alleged abuser from the person who uses services and 

others who may be at risk or managing the risk by removing the 

opportunity for abuse to occur, where this is within the control of the 

provider 

– reporting the alleged abuse to the appropriate authority 

– reviewing the person’s plan of care to ensure that they are properly 

supported following the alleged abuse incident. 

●● Using information from safeguarding concerns to identify non-compliance, 

or any risk of non-compliance, with the regulations and to decide what will 

be done to return to compliance. 


●● Works collaboratively with other services, teams, individuals and agencies 

in relation to all safeguarding matters and has safeguarding policies that 

link with local authority policies. 

●● Participate in local safeguarding children boards where required and 

understand their responsibilities and the responsibilities of others in line 

with the Children Act 2004. 

●● Participate in safeguarding adult boards where required. 

●● Has clear procedures followed in practice, monitored and reviewed in place 

about the use of restraint and safeguarding. 

●● Takes into account relevant guidance set out in the Care Quality 


People who use services are protected as staff and others involved in 

carrying on the regulated activity are not: 

● 

● Able to benefit financially or inappropriately gain from a person who uses 

services; unless it is in line with their service’s arrangements, which should 

take account of other relevant professional guidance. 


7D 

7E 


●● Involved in writing wills or bequests of people who use services. 

●● Able to use property of people who use services for personal use. 

●● Able to borrow money from, or lend money to, people who use services. 

●● Able to sell or dispose of goods belonging to people who use services for 

their own gain. 

Ensure personalised care 

People who use services receive care, treatment and support from all 

staff who: 

●● Are committed to maximising people’s choice, control and inclusion and 

protecting their human rights as important ways of meeting their individual 

needs and reducing the potential for abuse. 

●● Recognise their personal responsibility in safeguarding people who use 

services. 

People who use services receive care, treatment and support from staff 

who, in relation to safeguarding: 

●● Know how to identify, report and respond appropriately to suspected or 

actual abuse because there are clear procedures that are followed in 

practice, monitored and reviewed. 

●● Recognise the impact that diversity, beliefs and values of people who use 

services can have. 

●● Are aware of and understand what abuse is, including the differences 

between supporting children and adults who are at risk of abuse. 

●● Understand the risk factors for abuse and what they must do if a person is 

being abused, suspected of being abused, is at risk of abuse or has been 

abused. 

●● Follow the referral process and timescales as described in all relevant local 

and national multi-agency procedures when responding to suspected 

abuse. They will take account of circumstances of the person using the 

service to identify and respond appropriately to other potential risk of 

abuse. 

●● Understand the roles of other organisations who may be involved in 

responding to suspected abuse to the extent that is appropriate to 

their role. 

●● Contribute to actions required including sharing information and attending 

forums. 

●● Work collaboratively with all relevant services, teams and agencies to 

safeguard and protect the welfare of people who use services. 


95 

7


7F 

7G 

●● Cooperate and work collaboratively with all relevant services, teams and 

agencies during any investigative process. 

●● Take part in regular reviews of the care, treatment and support outcomes 

against specific plans for people who use services. 

●● Are confident to report any suspicions without fear that they will suffer as a 

result. 

●● Are confident to report concerns without worrying about consequences, as 

they are aware of their rights under the Public Interest Disclosure Act 1998. 

●● Follow the protection plan agreed through the multi-agency procedures in 

order to reduce the risk of further abuse after an actual or suspected case 

of abuse. 

People who use services receive care, treatment and support from all 

staff who, in relation to restraint: 

●● Know and understand the different forms that restraint can take. 

●● Understand when different types of restraint are or are not appropriate, 

prioritising de-escalation or positive behaviour support over restraint 

wherever possible. 

●● Understand that restraint should be used in a way that respects dignity and 

protects human rights wherever possible. 

●● Know whether and what type of restraint is permitted in the service in 

which they are working. 

●● Understand that restraint should only be used as a last resort, and that the 

type of restraint used should be the least restrictive and for the minimum 

amount of time to ensure that harm is prevented and that the person, and 

others around them, are safe. 


who, in relation to responding to behaviour that presents a risk to 

themselves or others: 

●● Understand the value of a stimulating environment, meaningful activity 

and effective communication in preventing behaviour that presents a risk, 

taking into account that over-stimulation can sometimes adversely impact 

the behaviour of people who use services. 

●● Understand what can potentially trigger behaviour that presents a risk for 

each person or to others. 

●● Have the skills and knowledge to respond at an early stage and do so to 

reduce the likelihood of this behaviour happening or recurring. 

●● Respond in a person-centred way. 


7H 

7I 


●● Have the opportunities to talk about how they prevent and manage 

behaviour with others so that learning is shared and the risk of further 

incidents is reduced. 

People who use services benefit from practice where the use of restraint 

and management of behaviour that presents a risk is: 

●● Always risk assessed to ensure the appropriate techniques are used. 

●● Practised in a way that protects the dignity and respect of people who use 

services and protects their human rights. 

●● Discussed, agreed and documented in advance, wherever possible, with the 

person who uses services as part of the processes for planning care. 

●● Identified and documented in a plan that sets out preferred measures to 

prevent and minimise the use of restraint, which is reviewed as the person’s 

needs change. 

●● Used as a last resort and is the minimum response necessary for the 

shortest possible time, to make them and others as safe as possible. 

●● Recorded. 

●● Where applicable, used in line with the restraint guidelines in the Mental 

Capacity Act 2005 Code of Practice and the Mental Health Act 1983 Code 

of Practice and including a best interest assessment. 

●● Followed by an assessment whenever restraint is used of the person 

restrained and others involved in restraint for signs of injury and any 

emotional or psychological impact. 

People who use services that have been abused or are suspected of 

being abused (or where appropriate, people acting on their behalf) are: 

●● Taken seriously and treated with dignity and respect when they report 

abuse. 

●● Provided with appropriate help and support to report abuse. 

●● Supported by the service to take part in the safeguarding process to the 

extent to which they want or are able to, or to which the process allows. 

They are kept informed of progress. 

●● Made aware of, and supported to access, sources of support outside the 

service including local independent information advice, independent 

mental capacity advocacy services or independent mental health advocacy 

services where relevant. 

●● Provided with support, or given information about how they can obtain 

support, for as long as they need it. 

●● Confident that their care, treatment and support will not be compromised 

if they raise issues of abuse. 


97 

7


7J 

7K 

7L 


People who use services have access to information about: 

●● What abuse is and how to recognise the signs. 

●● What they should do if they or another person are being abused or suspect 

abuse, including relevant contact details under the local safeguarding 

procedures. 

●● What they might expect to happen when a referral is made under the local 

safeguarding procedures. 


●● Can be confident that information about a safeguarding concern is 

appropriately shared in line with multi-agency procedures, taking into 

account the sensitive nature of the information. 

●● Can be assured that safeguarding procedures are delivered in a way that 

protects people’s human rights, including their human rights to life and not 

to be treated in an inhuman or degrading way. 

●● Are confident that staff required to use restrictive physical interventions 

have received specialist training. 





to you. 

People who use services are confident: 

●● That where they are not covered by the Mental Health Act 2007, the 

service will, if allowed by legislation, only request authorisation under the 

Mental Capacity Act 2005 Deprivation of Liberty Safeguards, when it is in 

the best interests of the person who uses services and that person lacks 

capacity. 

● 

● The service will implement and review any subsequent authorisation in line 

with guidance. 


7M 

7N 



ACS ✔ AMB BTS CHC CHN ✔ CHS ✔ DCC 




People who use services know that where the service looks after 

people’s money and valuables: 

●● Individualised records (including receipts) are kept showing details of all 

income received, money spent and valuables held. 

●● They are not used by the service for the running or management of the 

service. 

●● The manager only becomes their agent where there is no suitable person 

outside the service available to undertake that role. 

●● They can access their money and valuables in a timely way. 





RHS RSM ✔ SHL SLS SMC SPC ✔ UCS 

People who use services know that where the service looks after 

people’s money and valuables: 

●● They are not used by the service for the running or the management of the 

service. 

●● The Shared Lives carer will only become their agent where there is no 

suitable person outside the service available to undertake that role. 

●● They can access their money and valuables in a timely way. 


99 

7


7O 

7P 





RHS RSM SHL ✔ SLS SMC SPC UCS 

People who use services can be confident that staff, and others involved 

in carrying on the regulated activity, will not: 

●● Take any person (including children) or pets into the home of the person 

using the service without their permission and that of the manager of the 

service. 





RHS RSM SHL ✔ SLS ✔ SMC SPC ✔ UCS 

People who use services can be confident that rapid tranquilisation will 

only be used if it is: 

●● Undertaken in line with evidence based guidelines including the National 

Institute for Health and Clinical Excellence’s clinical guideline on Violence: 

The short-term management of disturbed/violent behaviour in in-patient 

psychiatric settings and emergency departments (2005). 







7Q 


People who use services are protected from the risk and likelihood of 

abuse because staff: 

●● Assess the risk and history of abuse and the person’s vulnerability to abuse, 

including predatory behaviour or sexual vulnerability. 

●● Manage any identified risks to the person using the service and others. 







101 

7


Outcome 8: Cleanliness and infection 

control 

Regulation 

➜ 


Cleanliness and infection control 

12.—(1) The registered person must, so far as reasonably practicable, 

ensure that— 

(a) service users; 

(b) persons employed for the purpose of the carrying on of the 

regulated activity; and 

(c) others who may be at risk of exposure to a health care associated 

infection arising from the carrying on of the regulated activity, 

are protected against identifiable risks of acquiring such an infection by 

the means specified in paragraph (2). 

(2) The means referred to in paragraph (1) are— 

(a) the effective operation of systems designed to assess the risk of and 

to prevent, detect and control the spread of a health care associated 

infection; 

(b) where applicable, the provision of appropriate treatment for those 

who are affected by a health care associated infection; and 

(c) the maintenance of appropriate standards of cleanliness and hygiene 

in relation to— 

(i) premises occupied for the purpose of carrying on the regulated 

activity, 

(ii) equipment and reusable medical devices used for the purpose of 

carrying on the regulated activity, and 

(iii) materials to be used in the treatment of service users where such 

materials are at risk of being contaminated with a health care 

associated infection. 




Outcome 

➜ 

Outcome 8: Cleanliness and infection control 


Providers of services comply with the requirements of regulation 12, 

with regard to the Code of Practice for health and adult social care on 

the prevention and control of infections and related guidance. 

We are not required by the Act to produce guidance about the prevention 

or control of healthcare-associated infections. In this publication, there is 

no guidance about regulation 12 of the Health and Social Care Act 2008 

(Regulated Activities) Regulations 2010. The guidance is available in the 

Department of Health’s publication: The Code of Practice for health and adult 

social care on the prevention and control of infections and related guidance. 


103 

8



Regulation 

➜ 

Outcome 


Management of medicines 

13. The registered person must protect service users against the risks 

associated with the unsafe use and management of medicines, by means 

of the making of appropriate arrangements for the obtaining, recording, 

handling, using, safe keeping, dispensing, safe administration and 

disposal of medicines used for the purposes of the regulated activity. 




experience? 


●● Will have their medicines at the times they need them, and in a safe 

way. 

●● Wherever possible will have information about the medicine being 

prescribed made available to them or others acting on their behalf. 


●● Handle medicines safely, securely and appropriately. 

●● Ensure that medicines are prescribed and given by people safely. 

●● Follow published guidance about how to use medicines safely. 


Prompts 

➜ 

9A 

9B 



Providing personalised care through the effective use of 

medicines 

People who use services receive care, treatment and support that: 

●● Ensures the medicines given are appropriate and person-centred by taking 

account of their: 

– age 

– choices 

– lifestyle 

– cultural and religious beliefs 

– allergies and intolerances 

– existing medical conditions and prescriptions 

– adverse drug reactions 

– recommended prescribing regimes. 

●● Ensures the person’s prescription for medicines, for which the service is 

responsible, is up to date and is reviewed and changed as their needs or 

condition changes. 

●● Includes monitoring the effect of their medicines and action when 

necessary if their condition changes, including side effects and adverse 

reactions. 

●● Includes supporting and reminding them to self-administer their medicines 

independently where they are able and wish to do so by minimising the risk 

of incorrect administration. 

●● Follows clear procedures in practice, which are monitored and reviewed, 

which explain how up-to-date medicines information and clinical reference 

sources for staff are made available. 

Manage risk through effective procedures about medicines 

handling 

Where people who use services receive care, treatment and support that 

involves medicines, the provider has: 

●● Clear procedures followed in practice, monitored and reviewed for 

medicines handling that include obtaining, safe storage, prescribing, 

dispensing, preparation, administration, monitoring and disposal. Wherever 

they are required these procedures include: 

– how medicines which are prescribed ‘as required’ (PRN) are handled 

and used 


105 

9


– ensuring that staff handling medicines have the competency and skills 

needed 

– the arrangements for giving medicines covertly where this is needed in 

accordance with the Mental Capacity Act 2005 

– the arrangements for requesting a second opinion in relation to 

medicines for people detained under the Mental Health Act 1983 

– the arrangements for recording when it is not possible for a person to be 

able to self-administer their medicines 

– the recording of when medicines are given to the person 

– the arrangements for reporting adverse events, adverse drug reactions, 

incidents, errors and near misses. These should encourage local and, 

where applicable, national reporting, learning and promoting an open 

and fair culture of safety 

– the arrangements to implement and act upon the recommendations of 

all relevant medicine-related patient safety communications issued via 

alert systems within the required timescales 

– an up-to-date list of medicines taken by the person being produced 

when they begin to use the service 

– the management of discharge medicine to allow for continuity of care 

until a new arrangement is made 

– the arrangements for medicines management following death. 

●● Clear procedures, that are followed in practice, monitored and reviewed, for 

controlled drugs, unless they are taken by the person themselves in their 

own home, including: 

– investigations about adverse events, incidents, errors and near misses 

– sharing concerns about mishandling. 

●● Systems in place to reflect on the findings of their service reviews and as it 

does so, learns from adverse events, incidents, errors and near misses 

relating to medicines that have occurred within the service and elsewhere, 

so that the risk of them being repeated is reduced to a minimum. 

● 

● Systems in place to ensure they comply with the requirements of the 

Medicines Act 1968 and the Misuse of Drugs Act 1971, and their 

associated regulations, the Safer Management of Controlled Drugs 

Regulations 2006, relevant health technical memoranda and professional 

guidance from the Royal Pharmaceutical Society of Great Britain and other 

relevant professional bodies and agencies. 


9C 

9D 

9E 



●● Takes into account relevant guidance set out in the Care Quality 




●● Ensures that wherever possible, information is available for people about 

the medicines they are taking, including the risks. 

●● Ensures information is available for people about medicines advisable for 

them to take for their health and wellbeing and also to prevent ill health. 

●● Ensures there is access for staff to up-to-date legislation and guidance 

related to medicines handling. 

●● Ensures best interest meetings are held with people who know and 

understand the person using the services when covert administration of 

medicines is being considered, to decide whether this is in the person’s best 

interest. 





to you. 

People who use services detained under the Mental Health Act 1983: 

●● Receive medicines that are duly authorised and administered in line with 

the Mental Health Act 1983 Code of Practice. 







107 

9


9F 

9G 

9H 

9I 


●● Follows clear procedures in practice, which are monitored and reviewed and 

that explain how staff may be permitted to administer homely remedies. 

Where people who use services receive support with their medicines, the 

provider has: 

●● Additional clear procedures followed in practice, monitored and reviewed 

for medicines handling that include obtaining, administration, monitoring 

and disposal. Wherever they are required these procedures include: 

– how clinical trials are carried out in line with relevant laws, current 

guidelines and ethics committee approval 

– sharing concerns about medicines handling. 

●● Established arrangements for obtaining pharmaceutical information by a 

person who understands the care, treatment or support that is provided 

by the service. 


●● Ensures medicines required for resuscitation or other medical emergencies 

are accessible in tamper evident packaging that allows them to be 

administered as quickly as possible. 

The guidance in 9F, 9G and 9H applies to the service types ticked below: 

ACS ✔ AMB ✔ BTS CHC CHN ✔ CHS ✔ DCC 


LDC LTC ✔ MBS ✔ MHC MLS ✔ PHS ✔ RCA 

RHS ✔ RSM ✔ SHL SLS SMC SPC ✔ UCS ✔ 


who: 

●● Ensure they make a record of any medication taken or reminded by the 

person using the service where this is part of the plan of care. 

●● Follow clear procedures, that are monitored and reviewed, that explain: 

– their role with regards to helping people take their medicines 

– what staff should do if the person using services is unable, or refuses, to 

take their medicines. 


9J 






RHS RSM SHL SLS ✔ SMC SPC UCS 


who: 

●● Ensure that patient safety alerts, rapid response reports and patient safety 

recommendations disseminated by the National Patient Safety Agency and 

which require action are acted upon within required timescales. 


ACS ✔ AMB ✔ BTS ✔ CHC ✔ CHN CHS DCC 

DCS ✔ DEN DSS ✔ DTS ✔ EXC HBC HPS 

LDC ✔ LTC MBS ✔ MHC ✔ MLS ✔ PHS RCA 

RHS ✔ RSM SHL SLS SMC ✔ SPC UCS ✔ 


109 

9


Outcome 10: Safety and suitability 

of premises 

Regulation 

➜ 


Safety and suitability of premises 

15.—(1) The registered person must ensure that service users and 

others having access to premises where a regulated activity is carried on 

are protected against the risks associated with unsafe or unsuitable 

premises, by means of— 

(a) suitable design and layout; 

(b) appropriate measures in relation to the security of the premises; and 

(c) adequate maintenance and, where applicable, the proper— 

(i) operation of the premises, and 

(ii) use of any surrounding grounds, 

which are owned or occupied by the service provider in connection with 

the carrying on of the regulated activity. 

(2) In paragraph (1), the term “premises where a regulated activity is 

carried on” does not include a service user’s own home. 




Outcome 

Prompts 

➜ 

➜ 

10A 



experience? 

People who use services and people who work in or visit the 

premises: 

●● Are in safe, accessible surroundings that promote their wellbeing. 


●● Make sure that people who use services, staff and others know they 

are protected against the risks of unsafe or unsuitable premises by: 

– the design and layout of the premises being suitable for carrying 

out the regulated activity 

– appropriate measures being in place to ensure the security of the 

premises 

– the premises and any grounds being adequately maintained 

– compliance with any legal requirements relating to the premises 

●● Take account of any relevant design, technical and operational 

standards and manage all risks in relation to the premises. 


The following prompts relate to all registered providers except where care, 

treatment and support is delivered in a person’s own home. 

Ensure the premises are adequate 

People who use services and others who work in or visit the premises 

can be confident that in relation to design and layout, the provider: 

●● Ensures the premises are suitable for the regulated activity. 

●● Takes account of identified risks. 

●● Meets the requirements of the Health and Safety at Work Act 1974 and 

associated regulations and the Regulatory Reform (Fire Safety) Order 2005 

and other relevant legislation. 

●● Ensures the premises protect people’s rights to privacy, dignity, choice, 

autonomy and safety. 

●● Ensures the premises have space, heating, lighting and ventilation that 

conform to relevant and recognised standards. 


111 

10


10B 

●● Ensures the premises are accessible to people who need to enter the 

premises and meet the appropriate requirements of the Disability 

Discrimination Act 1995. 

●● Ensures the premises are free from preventable offensive odours. 

●● Ensures the premises are designed and operated in a way that takes 

account of guidance from expert bodies in relation to specific needs. 

●● Takes account of the safety needs of people who enter or use the premises, 

including the safety of children and other vulnerable people where they are 

permitted to enter. 

●● Ensures there is space for a relative, carer or friend to be able to be with a 

child who uses services. 

●● Ensures that all safety precautions are in place and tested with regard to all 

specialist equipment and engineering systems that are physically fixed to 

the premises. 

●● Ensures care is taken to maintain a suitable and comfortable environment 

for treatment having regard to the impact from equipment in use. 

●● Ensures the premises reflect Department of Health published guidance. 

Lead effectively to manage risk about the premises 

People who work, visit or use services can be confident that, 

in relation to design and layout: 

●● Medical gas cylinders and pipe lines are properly installed and maintained 

in accordance with manufacturers’ instructions and patient safety 

communications relating to these are followed. 

●● There are arrangements and licences in place for the safe collection, 

classification, segregation, storage, handling, transport, treatment and 

disposal of clinical waste in line with current waste legislation. 

●● Arrangements are in place to meet the Control of Substances Hazardous to 

Health Regulations 2002 as amended. 

● 

● Where premises are altered or their use is changed, the continued safety 

and suitability of the premises is assessed. 


10C 

10D 

10E 



in relation to security of premises and grounds: 

●● There is a risk assessment of unauthorised access relevant to the type of 

premises, the services provided and the nature of people who use those 

services, and they implement and review procedures to take account of the 

risk assessment. 

●● Security arrangements are in place to protect people who use services and 

others who have access to the premises and any associated grounds. 

●● Measures are in place to protect the personal possessions of people who 

use services. 


in relation to maintenance of premises and grounds, renewal 

and service continuity: 

●● There are clear procedures, followed in practice, monitored and reviewed, 

which cover: 

– how the premises are maintained 

– the identification, assessment, management and review of risks 

– where necessary the prevention, collection, storage, handling, transport, 

treatment and disposal of waste. 

●● Plans are developed and implemented for the adaptation of the premises in 

response to changes in: 

– the needs of people who use services 

– design, technical and operational guidance issued by appropriate expert 

bodies 

– how the service intends to provide regulated activities 

– relevant legislation. 

●● Appropriate risk assessments are undertaken regarding the safety and 

suitability of the premises, when the provider is not responsible for the 

premises in which the care, treatment and support is delivered. 

●● Relevant guidance is taken into account, including that from the Care 


People who use services, and staff understand: 

●● What to do in the event of an emergency. 


113 

10


10F 

10G 

10H 





to you. 

People who use services and others who work in or visit the premises 

can be confident that in relation to design and layout, the premises: 

●● Are designed and adapted so that people can move around and be as 

independent as possible in activities of daily living, and meet the 

appropriate requirements of the Disability Discrimination Act 1995. 

●● Have safe and secure storage facilities, including storage for the private 

belongings of people who use services. 

●● Have sufficient toilets, and where necessary bathroom and bathing 

facilities, that take into account people’s diverse needs and promote their 

privacy, dignity and independence. 

●● Have access to facilities for infant feeding, including facilities to support 

breastfeeding. 

●● Have call alarm systems that enable people who use services to get help 

when their mobility is limited for whatever reason. 

●● Have a system to enable staff to summon urgent assistance. 

●● Have somewhere private available for breaking bad news, where this 

is done. 


in relation to design and layout: 

●● The management of electrical, heating, safety and building facilities 

complies with statutory requirements and manufacturers’ instructions and 

are managed to minimise risk. 

●● There are fully planned and practised fire evacuation procedures. 


in relation to maintenance and renewal: 

●● There are clear procedures, followed in practice, monitored and reviewed, 

which cover: 

– what will happen in the event of electricity, water or gas supply failure 

– what will happen in the event of a fire or flooding 

– other emergencies that occur on the premises 


10I 

10J 


– how the situation will be managed should IT or communication systems, 

which are integral to the premises, fail. 

●● There are systems in place to ensure that the décor of the building is 

maintained and refreshed. 

●● The management of risk includes the prevention and control of Legionella. 

The guidance in 10F, 10G and 10H applies to the service types ticked below: 

ACS ✔ AMB BTS CHC ✔ CHN ✔ CHS ✔ DCC 


LDC ✔ LTC ✔ MBS MHC ✔ MLS ✔ PHS ✔ RCA 

RHS ✔ RSM ✔ SHL SLS SMC ✔ SPC ✔ UCS ✔ 

People who use services and others who work in, or visit the premises 

can be confident that in relation to design and layout, the premises: 

●● Have space for social, therapeutic, cultural, educational and play activities 

that meet the needs of people who use services. 

●● Have space for a relative, carer or friend to be able to stay with the person 

using the service at the end of their life. 


ACS ✔ AMB BTS CHC ✔ CHN ✔ CHS ✔ DCC 

DCS DEN DSS DTS ✔ EXC HBC HPS ✔ 

LDC ✔ LTC ✔ MBS MHC ✔ MLS ✔ PHS RCA 

RHS ✔ RSM ✔ SHL SLS SMC ✔ SPC UCS 

People who work visit or use services can be confident that: 

●● Facilities exist and are maintained in line with legislation for the safe 

handling of radionucleides required for scanning and treatment. 



DCS DEN DSS ✔ DTS EXC HBC HPS 




115 

10


10K 

10L 

People who use services can be confident that the staff caring for them 

are able to work effectively, because: 

●● Where they remain on the premises, staff on call have adequate facilities 

that ensure comfort, privacy and the ability to rest properly, and have 

access to a telephone connected to the premises’ network. 






People who use the service have bedrooms that: 

●● Are single occupancy except where two people have made a positive choice 

to share. (Pre-existing care homes, which provided at least 80% of places 

in single rooms as at 16 August 2002, may continue to do so. Where they 

did not provide that percentage of places in single rooms as at that date, 

they provide at least the same percentage of places in single rooms as they 

provided as at 31 March 2002.) 

●● Are of a size and shape that supports their lifestyle, care, treatment and 

support needs and enables access for care, treatment and support and 

equipment. 

●● They can personalise and in which they can make choices about their 

environment, including temperature, furnishings and decor. 

●● For new build care homes and other care homes seeking to register for the 

first time, are no smaller than 12 square metres. 

●● For existing care homes, are no smaller than they were as at 31 March 

2010. 







10M 

10N 

People who use services have: 


●● Access to outdoor space; this could be outdoor areas, gardens or grounds 

that allow individuals to benefit from being outside. 

●● Access to communal rooms that are of sufficient size, and that provide 

opportunities to comfortably participate in social, therapeutic, cultural, 

daily living or educational activities, either individually or with others. 

●● Access to toilets, baths and showers that enable people to maintain privacy 

and dignity that are in close proximity to their living areas. 





RHS ✔ RSM ✔ SHL SLS SMC SPC UCS 

People who use services are able to access support from the service 

because: 

●● There are clear contingency procedures followed in practice, monitored and 

reviewed, should the communication systems that the service uses to 

enable people to access it, fail. 




LDC LTC MBS ✔ MHC MLS PHS RCA ✔ 



117 

10


10O 

People who use services receive care, treatment and support provided in 

a vehicle that: 

●● Complies with any legal standards for safety, suitability and insurance that 

apply. 

●● Is operated and maintained in line with legislation and the manufacturer’s 

recommendations. 


ACS AMB ✔ BTS ✔ CHC CHN CHS DCC 

DCS DEN DSS ✔ DTS EXC HBC HPS 




10P 


People who use services are protected from harm because: 

●● Appropriate building components, such as glass alternatives, are used that 

reduce the risk of self-harm. 

●● Fixtures, fittings and furniture are designed with regard to the avoidance of 

ligature points. 

●● There is appropriate layout for observations of people who use services 

receiving acute mental health care, treatment and support. 




LDC LTC MBS MHC ✔ MLS ✔ PHS ✔ RCA 



119 

10


Outcome 11: Safety, availability and 

suitability of equipment 

Regulation 

➜ 


Safety, availability and suitability of equipment 


protect service users and others who may be at risk from the use of 

unsafe equipment by ensuring that equipment provided for the purposes 

of the carrying on of a regulated activity is— 

(a) properly maintained and suitable for its purpose; and 

(b) used correctly. 

(2) The registered person must ensure that equipment is available in 

sufficient quantities in order to ensure the safety of service users and 

meet their assessed needs. 

(3) Where equipment is provided to support service users in their day to 

day living, the registered person must ensure that, as far as reasonably 

practicable, such equipment promotes the independence and comfort of 

service users. 

(4) For the purposes of this regulation— 

(a) “equipment” includes a medical device; and 

(b) “medical device” has the same meaning as in the Medical Devices 

Regulations 2002. 




Outcome 

Prompts 



experience? 

➜ 

11A 

People who use services and people who work in or visit the 

premises: 

●● Are not at risk of harm from unsafe or unsuitable equipment (medical 

and non-medical equipment, furnishings or fittings). 

●● Benefit from equipment that is comfortable and meets their needs. 


●● Make sure that equipment: 

– is suitable for its purpose 

– is available 

– is properly maintained 

– is used correctly and safely 

– promotes independence 

– is comfortable. 

●● Follow published guidance about how to use medical devices safely. 


The following prompts relate to all registered providers unless otherwise 

stated. The term ‘equipment’ always includes ‘medical devices’. 

Ensure equipment is adequate 

People are safe because, where equipment is provided or used as part 

of the regulated activity, the equipment is: 

●● Available in sufficient quantities to meet the needs of people who use the 

service. 

●● Safe to be used. 

●● Suitable for its stated purpose. 

●● Compliant with all relevant laws. 

●● Installed, used and maintained correctly with reference to the 

specifications, manufacturer’s instructions, legislation and appropriate 

guidance from expert bodies. 


121 

11


11B 

11C 

●● Properly maintained, tested, serviced and renewed under a recorded 

programme. 

●● Stored safely and securely to prevent theft, damage or misuse. 

People’s needs are met because staff using any equipment do so in a 

way that has regard to their dignity, comfort and safety and promotes 

their independence by: 

●● Actively listening to their preferences and thoughts about the equipment 

they need and how it is used. 

●● Supporting the person to understand how and why the equipment is being 

used. 

●● Taking care in the way they use the equipment to make sure the person is 

comfortable and safe. 

●● Using the equipment in a way that ensures the person’s privacy and 

dignity. 

Manage risk through effective procedures about equipment 

suitability 

People are safe because, where equipment is provided as part of the 

regulated activity, there are clear procedures followed in practice, 

monitored and reviewed. Wherever necessary these include: 

●● Identification, assessment and review of risk. 

●● Where risks are identified, a plan for how these are to be managed. 

●● How the equipment is maintained and used. 

●● Ensuring that all staff involved in using the equipment have the 

competency and skills needed, and where this is not possible, know what 

to do to ensure the people remain safe. 

●● How staff will know what to do when a person who uses services refuses to 

allow use of the equipment. 

●● The arrangements for adverse events, incidents, errors and near miss 

reporting. These should encourage local and, where applicable, national 

reporting, learning and promoting an open and fair culture of safety. 

●● The training of people who use services about any equipment they are 

given to use themselves. 

●● Best interest meetings with people who know and understand the person 

using the services to ensure that treatment and care are taken that reflect 

the person’s best interest. 

● 

● What will happen in the event of electricity, water or gas supply failure, or 

other emergencies, that affect the equipment used to meet the needs of 



11D 

11E 

11F 


Where people who use services receive care, treatment or support that 

involves the use of medical devices, the provider has: 

●● Clear procedures that are followed in practice, monitored and reviewed for 

the use of medical devices. Wherever they are required these procedures 

include: 

– implementing guidance issued by experts or professional bodies in 

relation to the medical devices used 

– acting on alerts from an expert or professional body or a product 

manufacturer. 

People who use services receive care, treatment and support from a 

service that: 



Providing personalised care through the effective use of 

medical devices 


●● Ensures the medical devices used to meet their needs are: 

– not reused if they are manufactured for single use only 

– only modified in line with manufacturer’s instructions or guidance 

– only purchased if they meet the necessary legal requirements 

– available when they are required for use 

– supplied with the necessary technical information so that the risk of 

using them incorrectly is minimised 

– permanently installed where appropriate, in accordance with 

manufacturer’s requirements and published guidance 

– only used by the person, or by staff, once they know how to use and 

operate them correctly 

– monitored while being used and action taken if they do not appear to be 

working correctly 

– routinely maintained in line with the manufacturer’s instructions and by 

people who are competent to do so 

– repaired when they break down by people who are competent to do so 

– disposed of or recycled, safely and securely. 


123 

11


11G 

11H 





to you. 

When equipment is used in a person’s own home: 

●● Staff address any concerns in a timely manner where they have identified 

problems around the safety of the equipment. 



DCS ✔ DEN ✔ DSS DTS EXC HBC HPS 


RHS RSM ✔ SHL ✔ SLS ✔ SMC SPC UCS 


●● Ensures equipment required for resuscitation or other medical emergencies 

is available and accessible for use as quickly as possible. Where the service 

requires it, this equipment is tamper proof. 


ACS ✔ AMB ✔ BTS CHC ✔ CHN ✔ CHS DCC 

DCS DEN ✔ DSS ✔ DTS ✔ EXC HBC ✔ HPS ✔ 

LDC LTC ✔ MBS ✔ MHC MLS ✔ PHS ✔ RCA 

RHS ✔ RSM ✔ SHL SLS SMC SPC ✔ UCS ✔ 




This section looks at what providers should do to make sure that they 

have the right staff with the right skills, qualifications, experience and 

knowledge to support people. It looks at training needs for staff and 

how they should be supported to carry out their role, including the time 

they will need away from work in order to take part in learning and 

development opportunities. 


12. Requirements relating to workers 

13. Staffing 

14. Supporting workers. 


125


Outcome 12: Requirements relating 

to workers 

Regulation 

➜ 


Requirements relating to workers 

21. The registered person must— 

(a) operate effective recruitment procedures in order to ensure that no 

person is employed for the purposes of carrying on a regulated 

activity unless that person— 

(i) is of good character, 

(ii) has the qualifications, skills and experience which are necessary 

for the work to be performed, and 

(iii) is physically and mentally fit for that work; 

(b) ensure that information specified in Schedule 3 is available in respect 

of a person employed for the purposes of carrying on a regulated 

activity, and such other information as is appropriate; 

(c) ensure that a person employed for the purposes of carrying on a 

regulated activity is registered with the relevant professional body 

where such registration is required by, or under, any enactment in 

relation to— 

(i) the work that the person is to perform, or 

(ii) the title that the person takes or uses; and 

(d) take appropriate steps in relation to a person who is no longer fit to 

work for the purposes of carrying on a regulated activity including— 

(i) where the person is a health care professional, informing the 

body responsible for regulation of the health care profession in 

question, or 

(ii) where the person is a social care worker registered with the 

General Social Care Council, informing the Council. 




Outcome 

Prompts 



experience? 

➜ 

12A 


●● Are safe and their health and welfare needs are met by staff who are 

fit, appropriately qualified and are physically and mentally able to do 

their job. 


●● Have effective recruitment and selection procedures in place. 

●● Carry out relevant checks when they employ staff. 

●● Ensure that staff are registered with the relevant professional 

regulator or professional body where necessary and are allowed to 

work by that body. 

●● Refer staff who are thought to be no longer fit to work in health and 

adult social care, and meet the requirement for referral, to the 

appropriate bodies. 


Manage quality by employing the right people 

People who use services benefit from staff (including volunteers, 

students, temporary and ancillary staff and practitioners working 

under practising privileges) who: 

In relation to recruitment: 

●● Are honest, reliable, trustworthy and treat the people who use services with 

respect. 

●● Are not discriminated against during the application or recruitment process. 

●● Are qualified and competent to carry out their role and meet the needs of 


●● Have been subject to the necessary checks as described in Schedule 3 of 

the Health and Social Care Act 2008 (Regulated Activities) Regulations 

2010, so that the provider is assured that the worker is suitable for their 

role. 

●● Have been subject to a check that they are registered with the Independent 

Safeguarding Authority (ISA): 


127 

12


– where they are undertaking a Safeguarding Vulnerable Groups Act 2006 

“regulated activity” or “controlled activity”; and 

– are required to be registered under the Scheme’s phasing-in 

arrangements. 

●● Are only allowed to start work before a full and satisfactory Criminal 

Records Bureau (CRB) check has been received where the provider has 

received an ISA Adult First check that confirms the staff member is not 

barred. In these circumstances the following safeguards are put in place: 

– an appropriately qualified and experienced member of staff is appointed 

to supervise them 

– wherever it is possible, this supervisor is on duty at the same time as the 

new worker, or is available to be consulted 

– new workers do not escort people away from the premises unless 

accompanied by a staff member for whom a full and satisfactory CRB 

check has been received. 

This only applies to those staff who are employed to work with adults. 

Those working with children must wait for a full CRB disclosure before 

starting work. 

●● Have demonstrated that they are legally entitled to work in the United 

Kingdom. 

●● Have demonstrated they meet the same standards of competency, 

qualification and experience for the role where they are recruited from 

outside the United Kingdom as they would have had they been trained in 

the United Kingdom. 

●● Are currently registered with the relevant professional regulator and/or 

professional body where appropriate, and only use a protected professional 

title where their qualifications and registration allows them to do so. 

●● Are aware of and adhere to any codes of professional conduct that apply to 

them. 

●● Are physically and mentally able to carry out their role, with a plan of 

support including reasonable adjustment where necessary. This means 

staff: 

– are not placed at risk by the work they will do because of an illness or 

medical condition they have 

– do not present a risk to people who use services because of an illness or 

medical condition they have. 

● 

● Are able to communicate effectively with people who use services and 

other staff, to ensure that the care, treatment and support of people who 

use services is not compromised. 


12B 

12C 


●● Are clear about their responsibilities because they have an up-to-date job 

description. 

●● Are clear about the roles and responsibilities of other members of their 

team so that they know what they can expect from other staff. 

In relation to qualifications, knowledge, skills and experience: 

●● Have relevant qualifications, knowledge, skills and experience to carry out 

their role. 

●● Where this is not possible and does not impact on the safe delivery of the 

service the staff member agrees to work towards gaining the skills and 

qualifications necessary. 

●● Where trainees and students are working, they are only given tasks and 

provide care, treatment and support that is appropriate to the stage of 

their training and their competence. 

●● Have their qualifications, knowledge and skills reviewed on a regular basis 

to ensure they keep up to date with current practice. 

●● Have an awareness and knowledge of diversity and human rights and have 

the competencies to support, appropriate to their role, the diverse needs 

and human rights of people who use services. 

●● Have a good understanding of the communication needs of the people 

who use the service. 

●● Can identify and respond to the changing needs of people who use 

services. 

●● Are knowledgeable of the individual needs and preferences of the people 

who use the service. 

●● Understand the physical and emotional needs of people who use services. 

●● Recognise and promote the independence of people who use services. 

●● Are aware of the services’ policies, procedures, legislation and standards. 

●● Know who they are able to contact, and how, when expert advice is 

needed. 

Lead effectively to ensure staff are suitable for their role 

People who use services receive a service from a provider that has the 

right staff because: 

●● Staff are recruited following an effective recruitment and selection 

procedure that complies with legislation about employment, equalities and 

human rights. This includes as a minimum when recruiting new staff: 

– application process including all of the necessary checks 

– interview 


129 

12


– references 

– records of the above. 

●● The recruitment and selection process ensures that staff are fit and 

physically and mentally able to perform their role. 

●● Temporary, agency, bank and voluntary staff, and any practitioner working 

under practising privileges, are subject to the same level of checks and a 

similar selection criteria as staff recruited directly. 

●● Other people providing additional services under arrangements made with 

the provider are subject to the necessary checks. 

●● Staff provided by an agency service are known to be fit and physically and 

mentally able to perform their role through: 

– confirmation in writing from the agency that all necessary checks have 

been carried out in relation to each staff member being supplied, 

including registration with the ISA in line with its phasing programme. 

– the provider quality monitoring the contract they have with the agency, 

where the agency is used on an ongoing basis. 

●● There are clear procedures followed in practice, monitored and reviewed, 

that are implemented when staff: 

– are not well enough to work 

– behave outside the policies and procedures of the service, or professional 

codes of conduct or practice that apply to them 

– should be referred to their professional regulator or professional body, 

as appropriate 

– are subject to investigations into suspected abuse 

– are reasonably suspected to have caused harm or risk of harm to people 

who use services, and this includes the requirement for the person to be 

referred to the Independent Safeguarding Authority and/or regulatory 

body where the requirements for referral are met 

– who are barred but are able to work in a Safeguarding Vulnerable Groups 

Act 2006 “controlled activity”. This includes the staff member being 

subject to tough safeguards including stringent supervision 

– require specific plans of support, including any reasonable adjustments, 

to enable them to carry out their job 

– are at risk of, or are, being exposed to physical, psychological or 

emotional hazards in the workplace in the course of their duties, and 

providing information about how those risks can be minimised. 

● 

● They take into account relevant guidance, including that from the Care 



12D 






to you. 


●● Staff are only allowed to start work before a full and satisfactory CRB 

check has been received where the provider has received an ISA Adult First 

check that confirms the staff member is not barred. In these circumstances 

the following additional safeguards are put in place: 

– the provider contacts people using the service, or others acting on their 

behalf, at weekly intervals to monitor their satisfaction with the care 

provided by the new worker and any complaints that may arise 

– the provider informs people using the service, or others acting on their 

behalf, about the outstanding information, and tells them when it is 

received 

– the provider ends the new worker’s contact with people using the service 

where the provider considers that the outstanding information (when 

received) is not satisfactory. 

This only applies to those staff who are employed to work with adults. 

Those working with children must wait for a full CRB disclosure before 

starting work. 

●● Staff are recruited with the involvement of people who use services where 

it is possible to do so. 




LDC ✔ LTC MBS MHC MLS PHS RCA 

RHS RSM SHL ✔ SLS ✔ SMC SPC ✔ UCS 


131 

12



Regulation 

➜ 

Outcome 

➜ 


Staffing 

22. In order to safeguard the health, safety and welfare of service users, 

the registered person must take appropriate steps to ensure that, at all 

times, there are sufficient numbers of suitably qualified, skilled and 

experienced persons employed for the purposes of carrying on the 

regulated activity. 




experience? 


●● Are safe and their health and welfare needs are met by sufficient 

numbers of appropriate staff. 


●● Make sure that there are sufficient staff with the right knowledge, 

experience, qualifications and skills to support people. 


Prompts 

➜ 

13A 



Lead effectively to ensure there are sufficient staff 

People who use services benefit from sufficient staff to meet their 

needs because the provider: 

●● Can demonstrate that there are sufficient numbers of staff with the right 

competencies, knowledge, qualifications, skills and experience to meet the 

needs of people who use services at all times. 

●● Can show that as far as possible that there are enough staff who know the 

needs of people using the service, meaning that people who use services 

can expect a consistency of care. 

●● Is able to demonstrate that they have carried out a needs analysis and risk 

assessment as the basis for deciding sufficient staffing levels. 

●● Has management structures, systems and clear human resources 

procedures followed in practice, monitored and reviewed that enable the 

effective maintenance of staffing levels. 

●● Can respond to unexpected changing circumstances in the service, for 

example to cover sickness, vacancies, absences and emergencies. 

●● Can respond to expected changing circumstances in the service, with 

particular regard to planned service developments, workforce changes, 

staff training, planned absences and changes in legislation. 




There are no additional prompts for this outcome. 


133 

13



Regulation 

➜ 


Supporting workers 

23.—(1) The registered person must have suitable arrangements in 

place in order to ensure that persons employed for the purposes of 

carrying on the regulated activity are appropriately supported in relation 

to their responsibilities, to enable them to deliver care and treatment to 

service users safely and to an appropriate standard, including by— 

(a) receiving appropriate training, professional development, supervision 

and appraisal; and 

(b) being enabled, from time to time, to obtain further qualifications 

appropriate to the work they perform. 

(2) Where the regulated activity carried on involves the provision of 

health care, the registered person must (as part of a system of clinical 

governance and audit) ensure that healthcare professionals employed 

for the purposes of carrying on the regulated activity are enabled to 

provide evidence to their relevant professional body demonstrating, 

where it is possible to do so, that they continue to meet the professional 

standards which are a condition of their ability to practise. 

(3) For the purposes of paragraph (2), “system of clinical governance 

and audit” means a framework through which the registered person 

endeavours continuously to— 

(a) evaluate and improve the quality of the services provided; and 

(b) safeguard high standards of care by creating an environment in 

which clinical excellence can flourish. 




Outcome 

Prompts 



experience? 

➜ 

14A 


●● Are safe and their health and welfare needs are met by competent 

staff. 


●● Ensure that staff are properly supported to provide care and treatment 

to people who use services. 

●● Ensure that staff are properly trained, supervised and appraised. 

●● Enable staff to acquire further skills and qualifications that are 

relevant to the work they undertake. 


Lead effectively to support staff 


who are competent to carry out their roles, because: 

●● All staff receive a comprehensive induction that takes account of 

recognised standards within the sector and is relevant to their workplace 

and their role. 

●● Induction is undertaken when they start their job and is completed before 

they are allowed to work unsupervised. 

●● The induction for new staff includes at least: 

– the aims, objectives and purpose of the service 

– information on the people whose care, treatment and support the staff 

member will be involved in providing and any specific communication 

needs 

– the rights of people who use the service 

– the policies and procedures of the service 

– the action to be taken in an emergency 

– the health and safety risk assessments and any necessary health 

surveillance, necessary for their work 

– how to report adverse events, incidents, errors and near misses 

– the arrangements for the staff member’s own support and supervision 


135 

14


– the support and the safety arrangements where they are required to 

work alone 

– the arrangements for reporting where the service falls below essential 

standards of quality and safety 

– An orientation to the systems, culture and terminology of the health and 

or social care sectors in England, where the staff member has been 

recruited from outside the UK. 

●● The learning and development needs of staff are identified based on the 

needs of people who use services and the skills needed from staff to ensure 

that the service meets essential standards of quality and safety. 

●● Staff have a learning and development plan in place from the point of 

induction based upon the needs identified and how those needs will be 

met. This takes account of recognised standards in the sector. 

●● The service has a learning and development plan which leads to the 

development of a programme of activity that meets mandatory, sector 

body and professional requirements for the designated roles and enables 

staff to meet their professional registration and development requirements. 

●● Staff are enabled to take part in learning and development that is relevant 

and appropriate so that they can carry out their role effectively. 

●● Where it applies, staff are supported to take accredited training. 

●● The staff learning and development programme takes account of the 

working patterns of staff. 

●● Where learning and development is delivered by a trainer, that person has 

demonstrated that they are competent to do so and, where an 

accreditation scheme applies, are accredited to act as a trainer for the 

course being provided. 

●● The programme of learning and development is supported by appropriate 

resources. 

●● Where necessary, the service works with relevant training providers to 

ensure the programme is delivered effectively. 

●● A record is kept of those attending the learning and development activities 

that staff attend. 

●● The competency of staff to provide care, treatment and support is assessed 

in light of their learning and development, and support is provided to them 

where gaps are identified. 

●● The learning and development plan for staff is reviewed and adjusted to 

meet the changing needs of the people who use the service and to ensure 

that the service is fully able to meet essential quality and safety standards. 

● 

● Staff receive the learning and development opportunities they need to 

carry out their role and keep their skills up to date. 


14B 

14C 

14D 


●● They take into account relevant guidance, including that from the Care 


Children who use services can be confident that: 

●● They are treated by staff who are appropriately trained to provide care, 

treatment and support for children, including Children’s Workforce 

Development Council Induction standards. 

People receive a service from a provider that supervises its staff, 

because: 

●● Staff are supported and managed at all times and are clear about their lines 

of accountability. 

●● Supervisory or peer support arrangements are in place, monitored and 

reviewed, for all staff involved in delivering care, treatment and support. 

This is in line with relevant national guidance from professional regulators 

and/or professional bodies, and is monitored and reviewed. These 

supervisory arrangements mean that: 

– staff can talk through any issues about their role, or about the people 

they provide care, treatment and support to, with their line manager or 

supervisor 

– a support structure is in place for supervision which includes one-to-one 

sessions or group meetings. They are undertaken at a time and 

frequency agreed between the line manager or supervisor and the staff 

member, and they are recorded. 

●● The development of staff is supported through a regular system of 

appraisal that promotes their professional development and reflects any 

relevant regulatory and/or professional requirements. 

People receive a service from a provider that supports its staff because: 

●● Where staff need reasonable adjustments in order to be able to carry out 

their role suitable plans are put in place for their ongoing support. 

●● Staff follow their professional codes of conduct, are supported to do so, 

and are not required to do anything that would mean they would fail to 

follow that code. 

●● Staff are supported to do their work in a safe working environment where 

risk of violence, harassment and bullying are assessed and minimised. 


that are implemented when staff are subjected to violence, harassment or 

bullying by other staff or people who use services. 

●● There is an open culture in the service which allows staff to feel supported 

to raise concerns without any fear of recrimination. 


137 

14


14E 

14F 

●● The risk to staff from the premises, equipment, or work that they do are 

assessed, and the preventative and protective measures that need to be 

followed are implemented. This includes staff understanding and following 

any health surveillance measures. 

●● There are arrangements to identify when a member of staff develops a 

health problem related to their work and to support them. 





to you. 

People who use services receive care treatment and support from staff 

who have undertaken: 

●● Skills for Care Common Induction Standards. 

●● Training and qualifications that satisfy the learning outcomes as advised by 

Skills for Care. 

●● Units or qualifications relevant to job role as advised by Skills for Care. 





RHS RSM ✔ SHL ✔ SLS ✔ SMC SPC ✔ UCS 


● 

● They are treated by staff who carry out sufficient levels of activity to 

maintain their competence, including in relation to specific anaesthetic and 

surgical procedures, taking account of guidance from relevant expert or 

professional bodies. 


14G 

14H 




DCS DEN DSS ✔ DTS ✔ EXC HBC HPS 



Children who use services: 

●● Can be confident that they are treated by staff who carry out sufficient 

levels of activity to maintain their competence, including in relation to 

specific anaesthetic and surgical procedures for children, taking account of 

guidance from relevant expert or professional bodies. 



DCS DEN DSS ✔ DTS ✔ EXC HBC HPS 



Children who use services: 

●● Receive care, treatment and support by staff registered by the Nursing and 

Midwifery Council on the parts of their register that permit a nurse to work 

with children, or the advice of such a nurse can be accessed at any time 

that it is needed. 



DCS ✔ DEN DSS ✔ DTS ✔ EXC HBC ✔ HPS ✔ 

LDC ✔ LTC ✔ MBS ✔ MHC ✔ MLS ✔ PHS ✔ RCA 



139 

14


14I 

14J 


●● Are cared for by staff who have received training about the assessment of 

suicide and homicide risk and behaviours that challenge. 







●● Are supported by healthcare professionals who are able to demonstrate to 

professional regulators that they continue to meet professional registration 

requirements because healthcare professionals are enabled by the service 

to collect all information required. 


ACS ✔ AMB ✔ BTS ✔ CHC ✔ CHN ✔ CHS DCC 







This section looks at what providers should do to manage risk in order to 

ensure that essential standards of quality and safety are maintained, and 

what information they must give to the Care Quality Commission about 

certain important events. 


15. Statement of purpose 

16. Assessing and monitoring the quality of service provision 

17. Complaints 

18. Notification of death of a person who uses services 

19. Notification of death or unauthorised absence of a person who is 

detained or liable to be detained under the Mental Health Act 1983 

20. Notification of other incidents 

21. Records. 


141



Regulation 

➜ 


Statement of purpose 

12.—(1) The registered person must give the Commission a statement 

of purpose containing the information listed in Schedule 3. 

(2) The registered person must keep under review and, where 

appropriate, revise the statement of purpose. 

(3) The registered person must provide written details of any revision to 

the statement of purpose to the Commission within 28 days of any such 

revision. 

SCHEDULE 3 

INFORMATION TO BE INCLUDED IN THE STATEMENT 

OF PURPOSE 

1. The aims and objectives of the service provider in carrying on the 


2. The kinds of services provided for the purposes of the carrying on of 

the regulated activity and the range of service users’ needs which those 

services are intended to meet. 

3. The full name of the service provider and of any registered manager, 

together with their business address, telephone number and, where 

available, electronic mail addresses. 

4. The legal status of the service provider. 

5. Details of the locations at which the services provided for the 

purposes of the regulated activity are carried on. 

Regulation 12 and Schedule 3 of the Care Quality Commission 

(Registration) Regulations 2009 


Outcome 

Prompts 



experience? 

➜ 


●● Will benefit from the knowledge that the Care Quality Commission is 

informed of the services being provided. 


●● Have a statement of purpose that is kept under review, and give a 

copy to the Care Quality Commission. 

●● Notify the Care Quality Commission of any changes to their statement 

of purpose. 

We have not produced any prompts for this regulation as the regulation is 

self-explanatory. Providers are reminded to read, understand and implement 

the full requirements of the regulation. 


143 

15


Outcome 16: Assessing and monitoring 

the quality of service provision 

Regulation 

➜ 


Assessing and monitoring the quality of service 

provision 

10.—(1) The registered person must protect service users, and others 

who may be at risk, against the risks of inappropriate or unsafe care and 

treatment, by means of the effective operation of systems designed to 

enable the registered person to— 

(a) regularly assess and monitor the quality of the services provided in 

the carrying on of the regulated activity against the requirements set 

out in this Part of these Regulations; and 

(b) identify, assess and manage risks relating to the health, welfare and 

safety of service users and others who may be at risk from the 

carrying on of the regulated activity. 


(a) where appropriate, obtain relevant professional advice; 

(b) have regard to— 

(i) the complaints and comments made, and views (including the 

descriptions of their experiences of care and treatment) 

expressed, by service users, and those acting on their behalf, 

pursuant to sub-paragraph (e) and regulation 19, 

(ii) any investigation carried out by the registered person in relation 

to the conduct of a person employed for the purpose of carrying 

on the regulated activity, 

(iii) the information contained in the records referred to in 

regulation 20, 

(iv) appropriate professional and expert advice (including any advice 

obtained pursuant to sub-paragraph (a)), 

(v) reports prepared by the Commission from time to time relating to 

the registered person’s compliance with the provisions of these 

Regulations, and 



(vi) periodic reviews and special reviews and investigations carried 

out by the Commission in relation to the provision of health or 

social care, where such reviews or investigations are relevant to 

the regulated activity carried on by the service provider; 

(c) where necessary, make changes to the treatment or care provided in 

order to reflect information, of which it is reasonable to expect that a 

registered person should be aware, relating to— 

(i) the analysis of incidents that resulted in, or had the potential to 

result in, harm to a service user, and 

(ii) the conclusions of local and national service reviews, clinical 

audits and research projects carried out by appropriate expert 

bodies; 

(d) establish mechanisms for ensuring that— 

(i) decisions in relation to the provision of care and treatment for 

service users are taken at the appropriate level and by the 

appropriate person (P), and 

(ii) P is subject to an appropriate obligation to answer for a decision 

made by P, in relation to the provision of care and treatment for a 

service user, to the person responsible for supervising or 

managing P in relation to that decision; and 

(e) regularly seek the views (including the descriptions of their 

experiences of care and treatment) of service users, persons acting 

on their behalf and persons who are employed for the purposes of 

the carrying on of the regulated activity, to enable the registered 

person to come to an informed view in relation to the standard of 

care and treatment provided to service users. 

(3) The registered person must send to the Commission, when requested 

to do so, a written report setting out how, and the extent to which, in 

the opinion of the registered person, the requirements of paragraph (1) 

are being complied with, together with any plans that the registered 

person has for improving the standard of the services provided to service 

users with a view to ensuring their health and welfare. 




145 

16


Outcome 

Prompts 

➜ 

➜ 

16A 


experience? 


●● Benefit from safe quality care, treatment and support, due to effective 

decision making and the management of risks to their health, welfare 

and safety. 


●● Monitor the quality of service that people receive. 

●● Identify, monitor and manage risks to people who use, work in or visit 

the service. 

●● Get professional advice about how to run the service safely, where 

they do not have the knowledge themselves. 

●● Take account of: 

– comments and complaints 

– investigations into poor practice 

– records held by the service 

– advice from and reports by the Care Quality Commission. 

●● Improve the service by learning from adverse events, incidents, errors 

and near misses that happen, the outcome from comments and 

complaints, and the advice of other expert bodies where this 

information shows the service is not fully compliant. 

●● Have arrangements that say who can make decisions that affect the 

health, welfare and safety of people who use the service. 


Lead effectively to manage risk 

Providers who are registered with the Care Quality Commission: 

In relation to monitoring the quality of services that people who use 

services receive: 

● 

● Have appropriate systems for gathering, recording and evaluating accurate 

information about the quality and safety of the care, treatment and 

support the service provides, and its outcomes. 



16B 

●● Gather information about the safety and quality of their service from all 

relevant sources, including: 

– feedback from people who use services or others acting on their behalf 

– observations 

– audits 

– adverse events, incidents, errors and near misses 

– investigations into the misconduct of a person employed 

– comments and complaints 

– claims 

– relevant expert and or professional bodies, including the findings of 

research projects they undertake 

– other comments received. 

●● Submit, where appropriate, information to be collected as part of a 

mandatory national data collection system. 

●● Use the findings from clinical and other audits, including those undertaken 

at a national level, and national service reviews to ensure that action is 

taken to protect people who use services from risks associated with unsafe 

care, treatment and support. 

●● Analyse and use the information gathered to identify non-compliance, or 

any risk of non-compliance, with the regulations and to decide what will be 

done to return to compliance. 

●● Reduce the risks identified in order to prevent the service becoming 

non-compliant with the regulations. 

In relation to making sure people who use services are not harmed as a 

result of unsafe care, treatment and support: 

●● Gather information about the risks to people’s health, welfare and safety. 

This includes people who use the service, the service’s staff, and anyone 

else involved in the regulated activities provided by the service. 

●● Make the necessary changes to the plan of care of a person who uses the 

service where the information gathered identifies a risk of inappropriate or 

unsafe care, treatment and support. 

●● Have a system to continuously identify, analyse and review risks, adverse 

events, incidents, errors and near misses. Information about this is used to 

develop solutions and risk reduction actions to ensure any non-compliance, 

or any risk of non-compliance, with the regulations is resolved as quickly as 

possible. 

●● Identify and analyse adverse events, incidents, errors and near misses to 

establish what caused them. 


147 

16


16C 

16D 

●● Make sure there is a confidential way for staff to raise concerns about risks 

to people, poor practice and adverse events. Staff understand the reporting 

system and feel confident to use it, without fear that they will be treated 

unfairly as a result of raising a concern. 

●● Involve people who use the service, others acting on their behalf, staff and 

all those who provide support in decisions about taking appropriate risks in 

a way that complies with relevant legislation. 

●● Provide people who use services with information about: 

– risks to their health, welfare and safety 

– any preventative or protective measures they should follow or use 

– their own responsibilities for contributing to safety. 

In relation to reporting on quality, risk, and improvement plans to 

ensure compliance with the regulations: 

●● Continually review their practice and take into account adverse events, 

incidents, errors and near misses that have occurred including the 

outcomes of complaints investigations within the service so that future 

lapses are minimised. 

●● Use information about the quality of experiences of people who use 

services, or others acting on their behalf, the views of staff and the risks 

they are exposed to, including the outcomes of comments, complaints and 

investigations, to understand where improvements are needed. 

●● Make information that may be produced about the quality of the service 

available to people who use services or are considering using it. 

●● Make, implement and review plans on quality, risk and improvement. 

In relation to decision‑making arrangements: 

●● Ensure that important decisions about care, treatment and support 

involve the person who uses the service and are supported by a written 

description of: 

– the names or job roles of people who can take each kind of decision or 

action 

– the names or job roles of people who must be consulted about, or agree 

to, particular decisions or actions. 

●● Set out the types of decision that require people who use services to be 

consulted and involved with. 

●● Set out what happens about decisions when the people who must be 

consulted are not available. 

● 

● Set out how and where the decisions, and the actions taken to make those 

decisions, are recorded. 



16E 


●● Have a continuous quality improvement system that is used to protect 

people who use services and others who may be at risk. 

●● Have an up-to-date description of the systems and methods the 

continuous quality improvement system uses to identify, assess, manage, 

monitor and record risks. 

●● Send this description to the Care Quality Commission when it is requested 

by the Commission. 

●● Take into account relevant guidance, including that from the Care Quality 





149 

16



Regulation 

➜ 


Complaints 

19.—(1) For the purposes of assessing, and preventing or reducing the 

impact of, unsafe or inappropriate care or treatment, the registered 

person must have an effective system in place (referred to in this 

regulation as “the complaints system”) for identifying, receiving, 

handling and responding appropriately to complaints and comments 

made by service users, or persons acting on their behalf, in relation to 

the carrying on of the regulated activity. 

(2) In particular, the registered person must— 

(a) bring the complaints system to the attention of service users and 

persons acting on their behalf in a suitable manner and format; 

(b) provide service users and those acting on their behalf with support 

to bring a complaint or make a comment, where such assistance is 

necessary; 

(c) ensure that any complaint made is fully investigated and, so far as 

reasonably practicable, resolved to the satisfaction of the service 

user, or the person acting on the service user’s behalf; and 

(d) take appropriate steps to coordinate a response to a complaint where 

that complaint relates to care or treatment provided to a service user 

in circumstances where the provision of such care or treatment has 

been shared with, or transferred to, others. 

(3) The registered person must send to the Commission, when requested 

to do so, a summary of the— 

(a) complaints made pursuant to paragraph (1); and 

(b) responses made by the registered person to such complaints. 




Outcome 

Prompts 



experience? 

➜ 

17A 

People who use services or others acting on their behalf: 

●● Are sure that their comments and complaints are listened to and acted 

on effectively. 

●● Know that they will not be discriminated against for making a 

complaint. 


●● Have systems in place to deal with comments and complaints, 

including providing people who use services with information about 

that system. 

●● Support people who use services or others acting on their behalf to 

make comments and complaints. 

●● Consider fully, respond appropriately and resolve, where possible, any 

comments and complaints. 


Lead effectively to manage complaints 

People who use services and those acting on their behalf can be 

confident that their comments and complaints are listened to and dealt 

with effectively because: 


for receiving, handling, considering and responding to comments and 

complaints, and a named contact who is accountable for doing so. 

●● The complaints process is available, understood and well-publicised, and 

reflects established principles of good complaint handling. The process will 

ensure: 

– that the details of the complaint, and the desired outcome, have been 

properly understood 

– that advice and advocacy support is available to those who wish or need 

such support 

– that what is required to resolve the complaint, and the likely timescale, 

is explained. 

●● Investigations are both proportionate and sufficiently thorough. 


151 

17


17B 

17C 

●● A documented audit trail of the steps taken and the decisions reached is 

kept. 

●● Consideration of the complaint is undertaken by staff who are competent 

to address the issues raised, provide honest explanations that are based on 

facts and include the reasons for the decisions made. 

●● Whenever possible complaints are reviewed by someone not involved in the 

events leading to the complaint. 

●● Comments and complaints are investigated and resolved to the satisfaction 

of the person raising the complaint unless: 

– the complaint falls outside the remit of the provider’s responsibility 

– the complaint cannot be upheld. 

●● The service has clear procedures followed in practice, monitored and 

reviewed for dealing with unreasonably persistent complainants in a fair 

and consistent manner, but ensures that the point they make is properly 

considered. 

●● The service encourages and supports a culture of openness that ensures 

any comment or complaint is listened to and acted on. 

●● The organisation ensures that a full record of the complaint is logged in 

line with the service’s procedures. 

●● The information from complaints is used to identify non-compliance, or any 

risk of non-compliance, with the regulations and to decide what will be 

done to return to compliance. 

●● The person knows how to contact the Care Quality Commission in order to 

inform the Commission of concerns they may have about the carrying on of 

the regulated activity. 

People who use services whose care, treatment and support is shared 

with more than one provider, or has been transferred to another 

provider, know that their comments and complaints are listened to 

because: 

●● The provider has agreed protocols in place to ensure that the services 

cooperate to provide one complete and coordinated response. 


● 

● Will produce a summary of complaints at a time and in a format set out by 

the Care Quality Commission and then send the summary within the time 

frame specified. 


17D 

17E 






People who use services or those acting on their behalf are able to use 

the comments and complaints process because: 

●● They are treated in a manner that respects their human rights and diversity 

in a fair and equal way. 

●● They know how to obtain or access information about the complaints 

system. 

●● Any comments and complaints are dealt with in a sensitive and timely 

manner by taking into account the individual circumstances. 

●● Their comments and complaints can be made either verbally, through sign 

language or in writing. 

●● Where they lack confidence or capacity to make a complaint, staff help 

them through the means the person who uses services finds most 

supportive. Alternatively, the provider accepts comments and complaints 

made by others acting on their behalf. 

●● Making a complaint will not cause them to be discriminated against or have 

any negative effect on their care, treatment or support. 

●● They are informed of the timescales and process that the provider will 

follow in responding to their complaint and be kept informed of progress. 

●● That they can ask the adult social services customer care manager to assist 

them in making a complaint where this applies. 

●● That they can use the NHS complaint process where their care, treatment 

and support was funded by the NHS, whether or not that care, treatment 

and support was provided in an NHS facility. 

●● They know the steps they can take if they are not satisfied with the 

findings or outcome once the complaint has been responded to, and are 

advised of their right to refer the matter to the next stage of the 

complaints system, including the Health Service Ombudsman, Local 

Government Ombudsman or Independent Sector Complaints Adjudication 

Service, where these options apply. 




153 

17


Outcome 18: Notification of death 

of a person who uses services 

Regulation 

➜ 


Notification of death of service user 

16.—(1) Except where paragraph (2) applies, the registered person 

must notify the Commission without delay of the death of a service 

user— 

(a) whilst services were being provided in the carrying on of a regulated 

activity; or 

(b) as a consequence of the carrying on of a regulated activity. 

(2) Subject to paragraph (4), where the service provider is a health 

service body, the registered person must notify the Commission of the 

death of a service user where the death— 

(a) occurred— 

(i) whilst services were being provided in the carrying on of a 

regulated activity, or 

(ii) as a consequence of the carrying on of a regulated activity; and 

(b) cannot, in the reasonable opinion of the registered person, be 

attributed to the course which that service user’s illness or medical 

condition would naturally have taken if that service user was 

receiving appropriate care or treatment. 

(3) Notification of the death of a service user must include a description 

of the circumstances of the death. 

(4) Paragraph (2) does not apply if, and to the extent that, the 

registered person has reported the death to the National Patient Safety 

Agency. 

(5) This regulation does not apply where regulation 17 applies. 




Outcome 

Prompts 



experience? 

➜ 

18A 

18B 

18C 

18D 

18E 


●● Can be confident that deaths of people who use services are reported 

to the Care Quality Commission so that, where needed, action can be 

taken. 

This is because: 

●● Providers notify the Care Quality Commission about the death of a 

person who uses the service. 


Informing the Care Quality Commission 

The regulations say that a registered person (provider or manager) 

must send notifications about deaths to the Care Quality Commission 

without delay. 

Where the registered person delegates this task to another member 

of staff, this must be included in the written description of decision‑ 

making arrangements required under Outcome 16. 

English NHS trusts send these notifications to the National Patient 

Safety Agency (NPSA), who will send them on to the Care Quality 

Commission. All other providers send their notifications directly to the 

Commission. 

These notifications must not identify the person they are about, or 

enable them to be identified. Individuals should be referred to using a 

code that is unique to them. Services must keep a record of these codes 

and who they refer to, in case the Care Quality Commission needs to 

make further enquiries. 

The death of a person who is detained, or liable to be detained, under 

the Mental Health Act 1983 is not notified under this outcome. Please 

refer to outcome 19 in these circumstances. 


155 

18


18F 

18G 

18H 

English NHS trusts only 

English NHS trusts inform the Care Quality Commission without delay 

of any death of a person using the service that occurred: 

●● While the service was being provided. 

●● That was a consequence of the service being provided; and 

●● Was not caused by an illness or condition that was being appropriately 

treated. 

English NHS providers must submit notifications under 18F to the Care 

Quality Commission by sending them to the NPSA. They must not be sent to 

the Care Quality Commission direct. 

Providers that are not English NHS trusts 

All providers that are NOT English NHS trusts inform the Care Quality 

Commission without delay of ALL deaths of a person using the service 

where they die while receiving, or as a result of, the care, treatment or 

support provided by the service. 

Notifications about deaths must include the following: 

●● A unique identifier or code for the person. 

●● The date they were admitted to or started using the service. 

●● The date and time of their death. 

●● The time the person was found. 

●● Where the person died. 

●● The cause of their death, where this is known. 

●● Whether the death was expected. 

●● If the death was not expected: 

– a unique identifier or code for the last person involved in providing care; 


– details of their job title and employer if this was not the provider. 

●● Details of any surgical procedure being used at the time of the person’s 

death or within the seven days before their death. 

●● Whether the person was being restrained at the time of their death, or 

within the seven days before their death. 

●● Whether there are concerns about the use of controlled or other drugs 

relating to the death. 

● 

● Whether there are concerns about the use of medical devices relating to 

the death. 



●● Relevant dates and circumstances, using unique identifiers and codes 

where relevant. 

●● Personal details about the person: 

– their date of birth 

– their gender 

– their ethnicity 

– any disability 

– any religion or belief 

– their sexual orientation. 




157 

18


Outcome 19: Notification of death or 

unauthorised absence of a person who 

is detained or liable to be detained under 

the Mental Health Act 1983 

Regulation 

➜ 


Notification of death or unauthorised absence of a 

service user who is detained or liable to be detained 

under the Mental Health Act 1983 

17.—(1) The registered person must notify the Commission without 

delay of the death or unauthorised absence of a service user who is 

liable to be detained by the registered person— 

(a) under the Mental Health Act 1983 (“the 1983 Act”); or 

(b) pursuant to an order or direction made under another enactment 

(which applies in relation to England), where that detention takes 

effect as if the order or direction were made pursuant to the 

provisions of the 1983 Act. 

(2) Notification of the death of a service user must include a description 

of the circumstances of the death. 

(3) In this regulation— 

(a) references to persons “liable to be detained” include a community 

patient who has been recalled to hospital in accordance with section 

17E of the 1983 Act, but do not include a patient who has been 

conditionally discharged and not recalled to hospital in accordance 

with section 42, 73 or 74 of the 1983 Act; 

(b) “community patient” has the same meaning as in section 17A of the 

1983 Act; 

(c) “hospital” means a hospital within the meaning of Part 2 of that Act; 


(d) “unauthorised absence” means an unauthorised absence from a 

hospital. 




Outcome 

Prompts 

Outcome 19: Notification of death or unauthorised absence of a person 

who is detained or liable to be detained under the Mental Health Act 1983 


experience? 

➜ 

19A 

19B 

19C 

19D 

19E 

19F 

19G 

People using the service who are detained under the Mental 

Health Act 1983: 

●● Can be confident that important events that affect their welfare, 

health and safety are reported to the Care Quality Commission so that, 

where needed, action can be taken. 


●● Notify the Care Quality Commission about the death or unauthorised 

absence of a person detained under the Mental Health Act 1983 who 

uses services. 



The regulations say that a registered person (provider or manager) must 

send notifications about deaths and unauthorised absences of patients 

detained or liable to be detained under the Mental Health Act 1983 to 

the Care Quality Commission without delay. 




All providers send notifications in relation to Outcome 19 directly to the 

Care Quality Commission. 

These notifications must not identify the person they are about, or 

enable them to be identified. Individuals should be referred to using a 

code that is unique to them. Services must keep a record of these codes 

and who they refer to, in case the Care Quality Commission needs to 

make further enquiries. 

Notification about the death of a person using the service must be 

made where the person dies while receiving, or as a result of, the care, 

treatment or support provided by the service. 

The death of a person who is detained, or liable to be detained, under 

the Mental Health Act 1983 is notified under this outcome only, and 

not notified under outcome 18. 

Unauthorised absences of a person liable to be detained under the 

Mental Health Act 1983 become notifiable when the person is still 

absent after midnight on the day their absence began. 


159 

19


19H 

19I 

Deaths 

All notifications about deaths and unauthorised absences of a person 

detained or liable to be detained under the Mental Health Act 1983 

must include the following: 


●● The date they were admitted to or started using the service. 

●● Relevant dates and circumstances, using unique identifiers and codes 


●● Personal details about the person: 

– their date of birth 

– their gender 

– their ethnicity 

– any disability 

– any religion or belief 

– their sexual orientation. 

Notifications under Outcome 19 that concern a death must also include 

the following: 

●● The date and time of the death. 

●● The time the person was found. 

●● Where the person died. 

●● The cause of their death, where this is known. 

●● Whether the death was expected. 

●● If the death was not expected: 

– a unique identifier or code for the last person involved in providing care; 


– details of their job title and employer if this was not the provider. 

●● Details of any surgical procedure being used at the time of the person’s 

death or within the seven days before their death. 

●● Whether the person was being restrained at the time of their death, or 

within the seven days before their death. 

●● Whether there are concerns about the use of controlled or other drugs 

relating to the death. 

● 

● Whether there are concerns about the use of medical devices relating to 

the death. 


Outcome 19: Notification of death or unauthorised absence of a person 

who is detained or liable to be detained under the Mental Health Act 1983 

19J 

Unauthorised absence 

Notifications under Outcome 19 that concern an unauthorised absence 

must also include the following: 

●● The section of the Mental Health Act 1983 under which the person is liable 

to be detained. 

●● The reasons for their detention. 

●● The circumstances in which they came to be absent. 




161 

19


Outcome 20: Notification of other 

incidents 

Regulation 

➜ 


Notification of other incidents 

18.— (1) Subject to paragraphs (3) and (4), the registered person must 

notify the Commission without delay of the incidents specified in 

paragraph (2) which occur whilst services are being provided in the 

carrying on of a regulated activity, or as a consequence of the carrying 

on of a regulated activity. 

(2) The incidents referred to in paragraph (1) are— 

(a) any injury to a service user which, in the reasonable opinion of a 

health care professional, has resulted in— 

(i) an impairment of the sensory, motor or intellectual functions of 

the service user which is not likely to be temporary, 

(ii) changes to the structure of a service user’s body, 

(iii) the service user experiencing prolonged pain or prolonged 

psychological harm, or 

(iv) the shortening of the life expectancy of the service user; 

(b) any injury to a service user which, in the reasonable opinion of a 

health care professional, requires treatment by that, or another, 

health care professional in order to prevent— 

(i) the death of the service user, or 

(ii) an injury to the service user which, if left untreated, would lead 

to one or more of the outcomes mentioned in sub-paragraph (a); 

(c) any request to a supervisory body made pursuant to Part 4 of 

Schedule A1 to the 2005 Act by the registered person for a standard 

authorisation, including the result of such a request; 

(d) any application made to a court in relation to depriving a service user 

of their liberty pursuant to section 16(2)(a) of the 2005 Act; 

(e) any abuse or allegation of abuse in relation to a service user; 

(f) any incident which is reported to, or investigated by, the police; 

(g) any event which prevents, or appears to the service provider to be 

likely to threaten to prevent, the service provider’s ability to continue 

to carry on the regulated activity safely, or in accordance with the 

registration requirements, including— 



(i) an insufficient number of suitably qualified, skilled and 

experienced persons being employed for the purposes of carrying 

on the regulated activity, 

(ii) an interruption in the supply to premises owned or used by the 

service provider for the purposes of carrying on the regulated 

activity of electricity, gas, water or sewerage where that interruption 

has lasted for longer than a continuous period of 24 hours, 

(iii) physical damage to premises owned or used by the service 

provider for the purposes of carrying on the regulated activity 

which has, or is likely to have, a detrimental effect on the 

treatment or care provided to service users, and 

(iv) the failure, or malfunctioning, of fire alarms or other safety 

devices in premises owned or used by the service provider for the 

purposes of carrying on the regulated activity where that failure 

or malfunctioning has lasted for longer than a continuous period 

of 24 hours. 

(3) Paragraph (2)(f) does not apply where the service provider is an 

English NHS body. 

(4) Where the service provider is a health service body, paragraph (1) 

does not apply if, and to the extent that, the registered person has 

reported the incident to the National Patient Safety Agency. 


(a) “the 2005 Act” means the Mental Capacity Act 2005; 

(b) “abuse”, in relation to a service user, means— 

(i) sexual abuse, 

(ii) physical or psychological ill-treatment, 

(iii) theft, misuse or misappropriation of money or property, or 

(iv) neglect and acts of omission which cause harm or place at risk of 

harm; 

(c) “health care professional” means a person who is registered as a 

member of any profession to which section 60(2) of the Health Act 

1999 applies; 

(d) “registration requirements” means any requirements or conditions 

imposed on the registered person by or under Chapter 2 of Part 1 of 

the Act; 

(e) “standard authorisation” has the meaning given under Part 4 of 

Schedule A1 to the 2005 Act; 

(f) “supervisory body” has the meaning given in paragraph 180 (in 

relation to a hospital in England) or paragraph 182 (in relation to 

a care home) of Schedule A1 to the 2005 Act; 


163 

20


Outcome 

Prompts 

(g) for the purposes of paragraph (2)(a)— 

(i) “prolonged pain” and “prolonged psychological harm” means 

pain or harm which a service user has experienced, or is likely to 

experience, for a continuous period of at least 28 days, and 

(ii) a sensory, motor or intellectual impairment is not temporary if 

such an impairment has lasted, or is likely to last, for a 

continuous period of at least 28 days. 




experience? 

➜ 

20A 

20B 


●● Can be confident that important events that affect their welfare, 

health and safety are reported to the Care Quality Commission so that, 

where needed, action can be taken. 


●● Notify the Care Quality Commission about incidents that affect the 

health, safety and welfare of people who use services, including: 

– injuries to people 

– making an application to depriving someone of their liberty 

– events which stop the registered person from running the service as 

well as they should 

– allegations of abuse 

– a police investigation. 



The regulations say that a registered person (provider or manager) must 

send notifications about incidents that affect people who use services 

to the Care Quality Commission without delay. 





20C 

20D 

20E 

20F 

20G 


English NHS trusts send SOME of these notifications to the National 

Patient Safety Agency (NPSA), who will send them on to the Care 

Quality Commission. This guidance says when NHS trusts should send 

notifications to the NPSA, and when they send them directly to the Care 

Quality Commission. 

Other providers send ALL notifications directly to the Care Quality 

Commission. 

These notifications must not identify individual people, or enable them 

to be identified. Individuals must be referred to using a code that is 

unique to them. Services must keep a record of these codes and who 

they refer to, in case the Care Quality Commission needs to make 

further enquiries. 

The two kinds of incidents and events that must be notified to the Care 

Quality Commission are: 

Incidents affecting a person who uses the service: 

– Injuries 

– Applications to deprive someone of their liberty under the Mental 

Capacity Act 

– Allegations of abuse. 

Events involving the service in a way that could affect all of the 

people who use it: 

– Incidents reported to the police 

– Events that stop or may stop the service from operating safely and properly. 

In all cases the notifications about an incident affecting a person must 

include: 


●● The date they were or will be admitted to the service. 

●● Their date of birth. 

●● Their gender. 

●● Their ethnicity. 

●● Any disability. 

●● Any religion or belief. 

●● Their sexual orientation. 

●● All relevant dates and circumstances, using unique identifiers and codes 


●● Anything you have already done about the incident. 


165 

20


20H 

20I 

Notifications about incidents and events affecting a person 

who uses the service while receiving, or as a result of, the 

care, treatment and support provided by the service 

Injuries 

Providers tell the Care Quality Commission without delay about events 

that lead to: 

●● Serious injury to any person who uses the service. 

●● An injury requiring treatment by a healthcare professional to avoid death or 

serious injury. 

These serious injuries include: 

●● Injuries that lead to or are likely to lead to permanent damage – or damage 

that lasts or is likely to last more than 28 days – to: 

– a person’s sight, hearing, touch, smell or taste 

– any major organ of the body (including the brain and skin) 

– bones 

– muscles, tendons, joints or vessels 

– intellectual functions, such as 

■● intelligence 

■● speech 

■● thinking 

■● remembering 

■● making judgments 

■● solving problems. 

●● Injuries or events leading to psychological harm, including: 

– post traumatic stress disorder 

– other stress that requires clinical treatment or support 

– psychosis 

– clinical depression 

– clinical anxiety 

– the development after admission of a pressure sore of grade 3 or above 

that develops after the person has started to use the service 

(European Pressure Ulcer Advisory Panel Grading) 

– any injury or other event that causes a person pain lasting or likely to 

last for more than 28 days 


20J 

20K 

20L 

20M 


– any injury that requires treatment by a healthcare professional in order to 

prevent: 

■● death 

■● permanent injury 

■● any of the outcomes, harms or pain described above. 

English NHS providers must submit notifications under 20I to the Care Quality 

Commission by sending them to the NPSA. They must not be sent to the Care 

Quality Commission direct. 

Applications to Supervisory Bodies or the Court of Protection to 

deprive a person of their liberty 

Providers of hospitals, care homes or care homes with nursing tell the 

Care Quality Commission without delay about any application by the 

service to a Supervisory Body to deprive an adult of their liberty. 

Providers of all services tell the Care Quality Commission without delay 

about any application by the service to the Court of Protection to 

deprive an adult of their liberty. 

All notifications about an application to deprive an adult of their liberty 

must include: 

●● The date of the application. 

●● The reasons for the application. 

●● Whether an application to deprive the person of their liberty has been 

made before. 

●● The address of the Supervisory Body or Court 

Events that stop or may stop the registered person from running the 

service safely and properly 

Providers inform the Care Quality Commission without delay about: 

●● A level of staff absence or vacancy, or damage to the service’s premises 

that mean that people’s assessed needs cannot be met. 

●● The failure of a utility for more than 24 hours. 

●● The failure of fire alarms, call systems or other safety-related equipment for 

more than 24 hours. 

●● Any other circumstances or events that mean the service cannot – or may 

not be able to – meet people’s assessed needs safely. 

English NHS providers must submit notifications under 20M to the Care 




167 

20


20N 

20O 

Allegations of abuse 

Providers inform the Care Quality Commission without delay of: 

●● Any suspicion, concern or allegation from any source that a person using 

the service has been or is being abused, or is abusing another person (of 

any age), including: 

– details of the possible victim(s), where this is known – the same 

information shown in paragraph 20F above 

– a unique identifier or code for the actual or possible abusers, together 

with, where it is known: 

■● the personal information shown in paragraph 20G above 

■● their relationship to the abused person 

– a unique identifier or code for any person who has or may have been 

abused by a person using the service, together with (where known): 

■● the same personal information shown in paragraph 20G above 

■● their relationship to the abused person 

– the person who originally expressed the suspicion, concern or allegation 

(using a unique identifier or code). 

●● See paragraph 20Q below in relation to English NHS trusts and allegations 

of abuse of children. 

In relation to where the alleged or possible victim of abuse is an adult 

the notification must include details of the allegation, including: 

●● Any relevant dates, witnesses (using unique identifiers or codes) and 

circumstances. 

●● Whether the allegation has been reported to local multi-agency 

safeguarding arrangements and/or the police. 

●● The type of abuse (using the categories in the Department of Health 

document No Secrets). 

●● Anything the registered person has done as a result of the allegation. 


20P 

20Q 

20R 


In relation to where the alleged or possible victim of abuse is a child or 

young person under 18 years, the notification must include details of 

the allegation, including: 

●● Any relevant dates, witnesses (using unique identifiers or codes) and 

circumstances. 

●● The date the allegation was notified to the police, local safeguarding 

children board and the strategic health authority (where appropriate). 

●● The type of abuse (using the categories in the Department for Children, 

Families and Schools document Working Together). 

●● Anything the registered person has done as a result of the allegation. 

Paragraphs 20N and 20P only apply to an English NHS trust where: 

●● The alleged abuser is a member of staff or volunteer working for the 

provider. 

●● The alleged abuser is another person who uses the service. 

●● The abuse is alleged to have occurred on the premises of the provider. 

●● English NHS trusts notify allegations of abuse of children to local 

multi-agency child protection arrangements. 

English NHS providers must submit notifications under 20Q to the Care 



Incidents reported to or investigated by the police 

Providers inform the Care Quality Commission without delay of: 

●● Any incident reported to or investigated by the police that is associated 

with the delivery of the service and affects or may affect the health, safety 

and welfare of a person using the service, its staff, or anyone who visits the 

service. These events include: 

– people who use services going missing 

– assault or malicious damage 

– theft of property or money belonging to people who use the service. 

The above requirement does not apply to English NHS trusts. 




169 

20



Regulation 

➜ 


Records 

20.—(1) The registered person must ensure that service users are 

protected against the risks of unsafe or inappropriate care and treatment 

arising from a lack of proper information about them by means of the 

maintenance of— 

(a) an accurate record in respect of each service user which shall include 

appropriate information and documents in relation to the care and 

treatment provided to each service user; and 

(b) such other records as are appropriate in relation to— 

(i) persons employed for the purposes of carrying on the regulated 

activity, and 

(ii) the management of the regulated activity. 

(2) The registered person must ensure that the records referred to in 

paragraph (1) (which may be in paper or electronic form) are— 

(a) kept securely and can be located promptly when required; 

(b) retained for an appropriate period of time; and 

(c) securely destroyed when it is appropriate to do so. 




Outcome 

Prompts 



experience? 

➜ 

21A 


●● Their personal records including medical records are accurate, fit for 

purpose, held securely and remain confidential. 

●● Other records required to be kept to protect their safety and wellbeing 

are maintained and held securely where required. 


●● Keep accurate personalised care, treatment and support records 

secure and confidential for each person who uses the service. 

●● Keep those records for the correct amount of time. 

●● Keep any other records the Care Quality Commission asks them to in 

relation to the management of the regulated activity. 

●● Store records in a secure, accessible way that allows them to be 

located quickly. 

●● Securely destroy records taking into account any relevant retention 

schedules. 


Manage risk through effective procedures about records 

People who use services can be confident that their personal records for 

their care, treatment and support are properly managed because: 

●● The service has clear procedures that are followed in practice, monitored 

and reviewed, to ensure personalised records and medical records are kept 

and maintained for each person who uses the service. 

●● Records about the care, treatment and support of people who use services 

are updated as soon as practical. 

●● Verbal communications about care, treatment and support are documented 

within personal records as soon as is practical. 

●● Records about care, treatment and support are clear, factual and accurate 

and maintain the dignity and confidentiality of the people who use 

services. 

●● Records are securely stored and transferred internally between departments 

and externally to other organisations, when required. 

●● Protocols exist with other organisations for secure information sharing. 


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21


●● Records about people who use services are used to plan appropriate care, 

treatment and support to ensure their rights and best interests are 

protected and their needs are met. 

●● The record of the current interaction is linked with any previous records 

that exist for that person, whenever the service is able to reliably identify 

the person. 

●● They, or others acting on their behalf, and relevant staff, are aware of and 

can access, and where appropriate, contribute to the record. 

●● They are assured that safe and secure records management arrangements 

will continue to be in place for the legally required period should the 

registered provider close operations. 

●● Where a request for access to a record is made, all legislation and guidance 

in respect of Freedom of Information Act 2000 and the Data Protection Act 

1998 is followed by all staff. 

●● Wherever they are relevant to the service, the following records are kept 

and for the periods of time stated: 

– risk assessments; retain the latest risk assessment until a new one 

replaces it 

– purchasing excluding medical devices and medical equipment; 

18 months 

– general operating policies and procedures; retain the current version and 

previous version for three years 

– any incidents, events or occurrences that require notification to the Care 

Quality Commission; three years 

– use of restraint or the deprivation of liberty; three years 

– detention; three years 

– maintenance of the premises; three years 

– maintenance of equipment; three years 

– electrical testing; three years 

– fire safety; three years 

– water safety; three years 

– medical gas safety, storage and transport; three years 

– money or valuables deposited for safe keeping; three years 

– staff employment; three years following date of last entry 

– duty rosters; four years after the year to which they relate 

– purchasing of medical devices and medical equipment; 11 years 

– final annual accounts; 30 years. 


21B 

21C 








to you. 


●● Their healthcare records are kept or disposed of in accordance with the 

Data Protection Act 1998, the Department of Health’s Records 

Management: NHS Code of Practice (Part 2), and other professional bodies 

standards where applicable to the service. 


ACS ✔ AMB ✔ BTS ✔ CHC ✔ CHN CHS DCC 


LDC LTC ✔ MBS ✔ MHC MLS ✔ PHS ✔ RCA ✔ 



●● Their social care records for adults are kept or disposed of in accordance 

with the Data Protection Act 1998 and three years from last date of entry. 

●● Their social care records for children are kept or disposed of in accordance 

with the Data Protection Act 1998 and 80 years from last date of entry. 




LDC ✔ LTC ✔ MBS MHC MLS PHS RCA 

RHS ✔ RSM ✔ SHL ✔ SLS ✔ SMC ✔ SPC ✔ UCS 


173 

21


21D 

People who use services are supported through clear procedures that 

are followed in practice, monitored and reviewed that: 

●● Record the pathway taken through an advice algorithm, as well as the 

outcome of the advice algorithm. 









This section looks at what providers and managers must do to show that 

they are suitable to run the service and that they keep the Care Quality 

Commission informed about relevant changes. 


22. Requirements where the service provider is an individual or 

partnership 

23. Requirement where the service provider is a body other than a 

partnership 

24. Requirements relating to registered managers 

25. Registered person: training 

26. Financial position 

27. Notifications – notice of absence 

28. Notifications – notice of changes. 


175


Outcome 22: Requirements where 

the service provider is an individual 

or partnership 

Regulation 

➜ 


Requirements where the service provider is an 

individual or partnership 

4.—(1) This regulation applies where a service provider (P) is an 

individual or a partnership. 

(2) P must not carry on a regulated activity unless P is fit to do so. 

(3) P is not fit to carry on a regulated activity unless P is— 

(a) an individual who carries on the regulated activity, otherwise than in 

partnership with others, and satisfies the requirements set out in 

paragraph (4); or 

(b) a partnership and each of the partners satisfies the requirements set 

out in paragraph (4); 

(4) The requirements referred to are that P or, where applicable, each of 

the partners is— 

(a) of good character; 

(b) physically and mentally fit to carry on the regulated activity and has 

the necessary qualifications, skills and experience to do so; and 

(c) able to supply to the Commission, or arrange for the availability of, 

information relating to themselves specified in Schedule 3. 





Outcome 

Prompts 


experience? 

➜ 

22A 


●● Have their needs met by the service because it is provided by an 

appropriate person. 


●● Register with the Care Quality Commission the appropriate people or 

persons who: 

– are of good character 

– are physically and mentally able to perform their role 

– have the necessary qualifications, skills and experience to carry on 

the regulated activity or, where it is an organisation, supervise its 

management. 


The following prompts relate to all registered providers who are an individual 

or a partnership. These prompts do not apply where the service provider is a 

body other than an individual or partnership. 

Lead effectively to manage risk of inappropriate providers 

People who use services receive care, treatment and support from a 

provider who has demonstrated that it: 

●● Is honest, reliable and trustworthy. 

●● Is competent to run the service. 

●● Is physically and mentally able to do the job, with plans of support for 

individuals to show what arrangements will be put in place including any 

reasonable adjustments to enable them to do their job, wherever necessary. 

●● Is appropriately skilled with the qualifications, knowledge and experience 

required to manage the regulated activity, where there is no separate 

registered manager. 

●● Has been subject to the necessary checks as described in Schedule 3 of the 

Health and Social Care Act 2008 (Regulated Activities) Regulations 2010, 

so that the provider is assured that the worker is suitable for their role. 

●● Has been subject to a check that they are registered with the Independent 

Safeguarding Authority where: 


177 

22


22B 

– they are undertaking a Safeguarding Vulnerable Groups Act 2006 

“regulated activity” or “controlled activity” 

– they are required to be registered under the Scheme’s phasing-in 

arrangements. 

●● Is able to respond to any registered manager requests for resources in order 

to meet essential standards of quality and safety. 

●● Is able to empower the registered manager, where one is employed, and 

appropriately delegate authority to them so that they can effectively run 

the service on a day-to-day basis. 

In relation to meeting the needs of people who use services, providers: 

●● Anticipate and understand the possible outcomes of their decisions and 

actions on people’s lives. 

●● Influence and negotiate to achieve the essential standards of quality and 

safety for people who use services by understanding the importance of 

putting them at the centre and encouraging choice and control. 

●● Know and understand how to safeguard people. 

●● Have knowledge and understanding of how equal opportunities and a 

respect for human rights and diversity are put in to practice when 

delivering the service. 

●● Put into practice the aims and objectives described in the statement of 

purpose and explain how the service will achieve these. 

● 

● Recognise when particular knowledge and skills are needed and take 

appropriate action. 



22C 

In relation to their legal responsibilities, providers: 

●● Inform the Care Quality Commission about any and all: 

– convictions, cautions, warnings, reprimands and bind overs they receive 

– actions taken against them by a regulatory and/or professional body 

– voluntary insolvency arrangements and circumstances made by an 

individual. 

●● Have appropriate knowledge of the Health and Social Care Act 2008 

(Regulated Activities) Regulations 2010 (Part 3 and Part 4) and the 

consequences of failing to take action on set requirements. 

●● Make sure that the service complies with relevant laws and takes into 

account relevant statutory codes of practice. 

●● Supply all necessary information that the Care Quality Commission may 

request as required by the Health and Social Care Act 2008 (Regulated 

Activities) Regulations 2010 (Part 3 and Part 4). 

●● Co-operate effectively with any statutory agencies’ investigations. 




179 

22


Outcome 23: Requirement where the 

service provider is a body other than 

a partnership 

Regulation 

➜ 


Requirement where the service provider is a body other 

than a partnership 

5.—(1) This regulation applies where the service provider is a body 

other than a partnership. 

(2) The body must give notice to the Commission of the name, address 

and position in the body of an individual (in these Regulations referred 

to as “the nominated individual”) who is employed as a director, 

manager or secretary of the body and who is responsible for supervising 

the management of the carrying on of the regulated activity by the 

body. 

(3) The registered person must take all reasonable steps to ensure that 

the nominated individual is— 


(b) physically and mentally fit to supervise the management of the 

carrying on of the regulated activity and has the necessary 

qualifications, skills and experience to do so; and 

(c) able to supply to the registered person, or arrange for the availability 

of, the information specified in Schedule 3. 




Outcome 

Prompts 

Outcome 23: Requirement where the service provider is a body 

other than a partnership 


experience? 

➜ 

23A 


●● Have their needs met because the management is supervised by an 

appropriate person. 


●● Have a nominated individual who: 

– is of good character 

– is physically and mentally able to perform their role 

– has the necessary qualifications, skills and experience to supervise 

the management of the regulated activity. 


The following prompts relate to all providers who are a body other than an 

individual or a partnership. These prompts do not apply where the service 

provider is an individual or partnership. 

Manage quality by notifying an appropriate nominated 

individual 

People who use services receive a service whose management is 

supervised by a nominated individual who: 

●● Has been notified in writing to the Care Quality Commission. 

●● Is of good character as they are honest, reliable and trustworthy. 

●● Is physically and mentally able to do the job, with a plan of support that 

sets out any reasonable adjustments where necessary. This means they: 

– do not present a risk to people who use services because of any illness or 

medical condition they have 

– are not placed at risk by the work they will do because of any illness or 


●● Is appropriately skilled with the qualification(s), knowledge and experience 

to supervise the management of the regulated activity. This means the 

nominated individual: 


181 

23




so that the provider is assured that the nominated individual is suitable for 

their role. 


Safeguarding Authority: 




arrangements. 

●● Has their qualifications, knowledge and skills updated on a regular basis. 

●● Has an awareness and knowledge of diversity and human rights and applies 

in practice the competencies to support people’s diverse needs and human 

rights. 

●● Is aware of the services’ policies, procedures, legislation and standards. 

●● Knows who they are able to contact when expert advice is needed. 

●● Is able to respond to any registered manager requests for resources in order 

to meet essential standards of quality and safety. 

●● Is able to empower the registered manager, where one is employed, and 

appropriately delegate authority to them so that they can effectively run 

the service on a day-to-day basis. 




Outcome 23: Requirement where the service provider is a body 

other than a partnership 


183 

23


Outcome 24: Requirements relating to 

registered managers 

Regulation 

➜ 

Outcome 


Requirements relating to registered managers 

6.—(1) A person (M) shall not manage the carrying on of a regulated 

activity as a registered manager unless M is fit to do so. 

(2) M is not fit to be a registered manager in respect of a regulated 

activity unless M is— 


(b) physically and mentally fit to carry on the regulated activity and has 

the necessary qualifications, skills and experience to do so; and 

(c) able to supply to the Commission, or arrange for the availability of, 

the information relating to themselves specified in Schedule 3. 




experience? 


●● Have their needs met because it is managed by an appropriate person. 


●● Have a registered manager who: 

– is of good character 

– is physically and mentally able to perform their role 

– has the necessary qualifications, skills and experience to manage 



Prompts 

➜ 

24A 



The following prompts relate to all registered providers wherever the service, 

or a part of the service, is managed by a Registered Manager. 

This only applies to registered NHS providers where the Care Quality 

Commission has decided to apply a registered manager condition. 

Lead effectively to manage risk of inappropriate managers 

People who use services receive a service from a manager who has 

demonstrated that they: 

●● Are of good character as they are honest, reliable and trustworthy. 

●● Are physically and mentally able to do the job, with a plan of support, 

showing any reasonable adjustments, where necessary. This means the 

manager: 

– does not present a risk to people who use services because of any illness 

or medical condition they have 

– is not placed at risk by the work they will do because of any illness or 


●● Have the qualifications, knowledge and experience to manage the 


●● Are appropriately skilled, including as a minimum: 

– effective communication skills to enable good communication with their 

staff and the people who use their service 

– basic management skills to ensure that the service is delivered to meet 

essential standards of quality and safety. 



so that the provider is assured that the nominated individual is suitable for 

their role. 


Safeguarding Authority: 




arrangements. 

●● Show that they are registered with the relevant professional regulators 

and/or professional bodies where appropriate, and comply with their 

requirements and codes of practice. 


185 

24


●● Show qualifications and competencies recognised by the relevant sector 

body or, where these don’t apply, are able to demonstrate relevant skills 

and experience. 

●● Have appropriate knowledge of the Health and Social Care Act 2008 

(Regulated Activities) Regulations 2010 (Part 3 and Part 4) and the 

consequences of failing to take action on set requirements. 

●● Anticipate and understand the possible outcomes of their decisions and 

actions on people’s lives and take appropriate action. 

●● Use resources effectively. 

●● Have delegated responsibility to make decisions where needed. 

●● Delegate appropriately by: 

– knowing what can or cannot be delegated 

– knowing what can be delegated to whom 

– understanding the competencies of staff and what is it appropriate for 

them to do 

– having clear descriptions of each member of staff’s role so that it is clear 

what should be delegated to whom 

– ensuring that staff have the time they need to complete any newly 

delegated tasks. 

●● Ensure that people are safeguarded from abuse. 

● 

● Have knowledge and understanding of how equal opportunities and 

a respect for human rights and diversity are put in to practice when 

delivering the service. 



●● Understand the importance of the delivery of the service in a personcentred 

way, by ensuring that people who use services have choice and 

control. 

●● Put into practice the statement of purpose. 

●● Have plans of support that will show what arrangements will be put into 

place and any reasonable adjustments to enable a particular person to do 

their job. 

●● Make appropriate use of resources and highlight any areas of concerns to 

the provider, where relevant. 

●● Inform the Care Quality Commission about any: 

– convictions, cautions, warnings, reprimands and bind overs they receive 

– any action taken against them by a professional body. 




187 

24



Regulation 

➜ 

Outcome 


Registered person: training 

7.—(1) If the service provider is— 

(a) an individual, the individual must undertake; 

(b) a partnership, it must ensure that one of the partners undertakes; or 

(c) a body other than a partnership, it must ensure that the nominated 

individual undertakes, 

from time to time such training as is reasonably practicable and 

appropriate to ensure that there are the necessary experience and skills 

available for carrying on the regulated activity. 

(2) The registered manager must undertake from time to time such 

training as is appropriate to ensure that the manager has the experience 

and skills necessary for managing the carrying on of the regulated activity. 




experience? 


●● Have their care, treatment and support needs met because there is a 

competent person leading the service. 


●● Undertake appropriate training. 


Prompts 

➜ 

25A 

25B 



Manage risk through effective procedures for learning and 

development 

People who use services benefit from a service that is competently run 

and has effective systems to meet the requirements of the regulations. 

This is because the registered persons undertake the training necessary 

to ensure they: 

●● Have the relevant skills and experience and apply these in their work. 

●● Apply up-to-date knowledge to effectively meet the needs of people who 

use services, including taking into account staffing and premises 

requirements. 

●● Have a clear organisational structure with well-defined, transparent and 

consistent lines of responsibility. 

●● Have effective processes and systems to identify, manage, monitor and 

report risks, which must include systems to gather information from people 

who use services, professionals, and published audits and reports. 

●● Use this information to reduce unacceptable risks and keep this under 

review. 

●● Have a clear understanding of the services’ policies, procedures, legislation 

and standards. 

In addition, where the registered person is in day‑to‑day charge of the 

service, people who use services benefit from effective management. 

This is because the registered persons: 

●● Have plans in place to keep their knowledge and skills up to date and 

participate in appropriate training and activities. This training ensures that 

they: 

– provide effective care, treatment and support to the people who use 

their service 

– uphold and promote the rights of the people who use their service 

– are able to meet the diverse needs of people who use their service and 

follow current legislation 

– put into practice the statement of purpose. 


189 

25


25C 





to you. 

People who use services benefit from a manager who: 

●● Has an appropriate qualification as advised by Skills for Care, or be working 

towards it when newly registered with the Care Quality Commission. 





RHS RSM ✔ SHL ✔ SLS ✔ SMC ✔ SPC ✔ UCS 




191 

25



Regulation 

➜ 

Outcome 


Financial position 

13.—(1) Subject to paragraph (2), the service provider must take all 

reasonable steps to carry on the regulated activity in such a manner as 

to ensure the financial viability of the carrying on of that activity for the 

purposes of— 

(a) achieving the aims and objectives set out in the statement of 

purpose; and 

(b) meeting the registration requirements prescribed pursuant to section 

20 of the Act. 

(2) This regulation does not apply where the service provider is— 

(c) an English local authority; or 

(d) a health service body. 




experience? 


●● Can be confident that the service provider is able to meet the financial 

demands of providing safe and appropriate services. 


●● Have the financial resources needed to provide and continue to 

provide the services as described in the statement of purpose to the 

required standards. 


Prompts 

➜ 

26A 



Ensure quality through adequate finances 

People who use services are confident that the provider has: 

●● The financial resources needed to provide and continue to provide the 

services as described in the statement of purpose to the required standards. 

●● Wherever it is available, insurance and suitable indemnity arrangements to 

cover potential liabilities arising from death, injury, or other causes, loss or 

damage to property, and other financial risks. 




193 

26


Outcome 27: Notifications – 

notice of absence 

Regulation 

➜ 


Notice of absence 

14.—(1) Subject to paragraphs (7) and (8), where— 

(a) the service provider, if the provider is the person in day to day 

charge of the carrying on of the regulated activity; or 

(b) the registered manager, 

proposes to be absent from carrying on or managing the regulated 

activity for a continuous period of 28 days or more, the registered 

person must give notice in writing to the Commission of the proposed 

absence. 

(2) Except in the case of an emergency, the notice referred to in 

paragraph (1) must be given no later than 28 days before the proposed 

absence commences or within such shorter period as may be agreed with 

the Commission and must contain the following information in relation 

to the proposed absence— 

(a) its length or expected length; 

(b) the reason for it; 

(c) the arrangements which have been made for the management of the 

carrying on of the regulated activity during the period of absence; 

(d) the name, address and qualifications of the person who will be 

responsible for the management of the carrying on of the regulated 

activity during that absence; 

(e) in the case of the absence of the registered manager, the 

arrangements that have been, or are proposed to be, made for 

appointing another person to manage the carrying on of the 

regulated activity during that absence, including the proposed date 

by which the appointment is to be made. 

(3) Where the absence referred to in paragraph (1) arises as the result of 

an emergency, the registered person must give notice of the absence to 

the Commission within 5 working days of its occurrence specifying the 

matters set out in paragraph (2)(a) to (e). 


Outcome 


(4) Where— 

(a) the service provider, if the provider is the person in day to day 

charge of the carrying on of the regulated activity; or 

(a) the registered manager, 

has been absent for a continuous period of 28 days or more, and the 

Commission has not been given notice of the absence, the registered 

person shall forthwith give notice in writing to the Commission 

specifying the matters set out in paragraph (2)(a) to (e). 

(5) The registered person must notify the Commission of the return to 

duty of the service provider or (as the case may be) the registered 

manager not later than 7 working days after the date of that return. 

(6) In this regulation “working day” means any day other than a 

Saturday, a Sunday, Christmas Day, Good Friday or a day which is a bank 

holiday in England and Wales within the meaning of the Banking and 

Financial Dealings Act 1971. 

(7) Subject to paragraph (8), this regulation does not apply where the 

service provider is a health service body. 

(8) Where the service provider is a health service body and is subject to 

a registered manager condition pursuant to regulation 5 or section 12(3) 

or (5) of the Act, this regulation shall have effect in relation any 

absence, proposed absence or return to duty of that registered manager. 




experience? 


●● Can have confidence that, if the person(s) in charge of their service is 

absent, it will continue to be properly managed and be able to meet 

their needs. 


●● Inform the Care Quality Commission: 

– about any significant planned absences from the service 

– about any significant unplanned absences 

– how the service will be run while they are away 

– when they return from a significant absence. 


195 

27


Prompts 

➜ 

27A 

27B 


The following prompts relate to all registered providers. 

The regulations say that a registered person who is an individual (provider 

or manager) must send these notifications to the Care Quality Commission. 

Where the registered person delegates this task to another member of 

staff, this must be included in the written description of decision-making 

arrangements required under Outcome 16. 

Inform the Care Quality Commission of absences of a 

registered person 

People who use services receive a service from a provider (where the 

provider is an individual) and/or registered manager who has made 

appropriate arrangements to cover their absence: 

In relation to planned absences of a registered provider who is in day‑ 

to‑day charge of the service or of a registered manager: 

●● Registered persons give the Care Quality Commission 28 days’ notice if 

they are going to be absent from the service for 28 or more days. 

●● Where an absence is planned less than 28 days before it begins, registered 

persons inform the Care Quality Commission without delay before the 

absence begins. 

In relation to an emergency absence of a registered provider who is in 

day‑to‑day charge of the service or of a registered manager that is likely 

to last more than 28 days: 

● 

● Inform the Care Quality Commission of the absence within five working 

days after it began. 


27C 

27D 


In relation to all notices of absence of a registered provider who is in 

day‑to‑day charge of the service or of a registered manager: 

●● Tell the Care Quality Commission: 

– the reason for the absence, and how long it will last, if it is known 

– who will run the service while the registered person is away 

– the name, address and qualifications of the person who will be 

responsible for the service while the registered person is away. 

●● If the length of the absence is unknown, propose to the Care Quality 

Commission how long the situation will continue before a new manager will 

be proposed for registration. 

In relation to returning from an absence of a registered provider who is 

in day‑to‑day charge of the service or of a registered manager: 

●● Inform the Care Quality Commission that they have returned to work no 

later than seven days after their return. 




197 

27


Outcome 28: Notifications – 

notice of changes 

Regulation 

➜ 


Notice of changes 

15.—(1) Subject to paragraph (2), the registered person must give 

notice in writing to the Commission, as soon as it is reasonably 

practicable to do so, if any of the following events takes place or is 

proposed to take place— 

(a) a person other than the registered person carries on or manages the 

regulated activity; 

(b) a registered person ceases to carry on or manage the regulated 

activity; 

(c) the name of a registered person (where that person is an individual) 

changes; 

(d) where the service provider is a partnership, any change in the 

membership of the partnership; 

(e) where the service provider is a body other than a partnership— 

(i) a change in the name or address of the body, 

(ii) a change of director, secretary or other similar officer of the 

body, or 

(iii) a change of nominated individual; 

(f) where the service provider is— 

(i) an individual, the appointment of a trustee in bankruptcy in 

relation to that individual, or 

(ii) a company or partnership, the appointment of a receiver, 

manager, liquidator or provisional liquidator in relation to that 

company or partnership. 

(2) Paragraph (1)(e)(ii) does not apply where the service provider is a 

health service body. 


Outcome 

Prompts 


(3) In this regulation, “nominated individual” means the individual who 

is employed as a director, manager or secretary of the body and whose 

name has been notified to the Commission as being the person who is 

responsible for supervising the management of the carrying on of the 

regulated activity by that body. 




experience? 

➜ 


●● Can be confident that, if there are changes to the service, its quality 

and safety will not be adversely affected. 


●● Inform the Care Quality Commission: 

– when the person who manages or carries on the service changes 

– when the registered details of the service and any individual, 

partnership or organisation who manage or carry it on, change 

– when the registered person becomes financially insolvent 

– when the service closes. 


The following prompts relate to all registered providers. 

The regulations say that a registered person (provider or manager) must send 

these notifications to the Care Quality Commission. Where the registered 

person delegates this task to another member of staff, this must be included 

in the written description of decision-making arrangements required under 

Outcome 1. 

Inform the Care Quality Commission 

People who use services receive a service from a registered provider and/or 

manager who has made appropriate arrangements to notify the Care Quality 

Commission of changes. 


199 

28


28A 

28B 

In relation to the people who manage or carry on the service: 

●● Registered providers tell the Care Quality Commission of any plans for a 

person other than a registered person to carry on or manage the service as 

soon as possible before they do so. 

●● Where a person other than a registered person begins to carry on or 

manage the service and it has not been possible to tell the Care Quality 

Commission before they start to do so, they tell the Care Quality 

Commission about the planned change without delay. 

In relation to the registered details of the service: 

●● Providers tell the Care Quality Commission as soon as possible about: 

– where a registered person is an individual; any changes to their name 

– the appointment a new registered manager, and 

■● the name of the new registered manager 

■● the date they will begin work 

– where the service provider is a partnership; any changes to the 

membership of a partnership 

– where the service provider is an organisation; any changes to the 

organisation’s: 

■● name 

■● business address 

■● officers (such as to the directors or secretary) 

■● nominated individual. 

The requirement to notify changes to officers does not apply to English NHS 

trusts 


28C 

28D 


In relation to changes to financial solvency: 

●● Inform the Care Quality Commission when: 

– where the provider is an individual or member of a partnership that 

is not a limited liability partnership; they have been made bankrupt 

or their estate has been sequestrated; or 

– where the provider is an organisation or limited liability 

partnership; that an administrator, receiver, liquidator or provisional 

liquidator has been appointed. 

This requirement does not apply to English NHS trusts 

Where a provider cannot tell the Care Quality Commission about any of 

these changes before they are made or take place, they do so without 

delay afterwards. 




201 

28



Appendices 

➜ 

Care Quality Commission: Guidance Care about Quality compliance Commission: Essential A quality standards service, of a quality and experience safety – March Guidance 2010 203

Appendix A 

204 

Appendix A: Glossary 

Abuse Abuse is defi ned by the Health and Social Care Act 2008 (Regulated 

Activities) Regulations 2010 as: 

● Sexual abuse 

● Physical or psychological ill-treatment 

● Theft, misuse or misappropriation of money or property, or 

● Neglect and acts of omission which cause harm or place at risk of harm. 

In addition, we have given further guidance about this term in ‘defi nitions 

of key terms’ (see page 34). 

Adequate Suffi cient for a specifi c requirement. 

Advance 

decision 

Adverse drug 

reaction 

A decision to refuse specifi ed medical treatment, made in advance by a 

person who has the mental capacity to do so. In this way, people can refuse 

medical treatment for a time in the future when they may lack the capacity 

to consent to, or refuse, that treatment. 

An unwanted or unexpected reaction to a medicine. 

Adverse event An event that is not anticipated or not known to be related to the person’s 

condition or the intervention being used. Adverse events include near 

misses. 

Advocacy The action of an advocate, or the services provided by one or more 

advocates. Taking action to help people to say what they want, securing 

their rights, representing their interests and obtaining the services they 

need. 

Advocacy is most effective when carried out by a person who is 

independent of the services being provided. 


Glossary 

Advocate Advocate can be used in a general sense, as one who speaks on behalf of 

another, or it can have special meanings derived from the Mental Health 

Act 1983 and the Mental Capacity Act 2005. 

Agreement 

(in relation to a 

signed 

document) 

Aids to daily 

living 

There are formal and informal advocates and these can be: 

● Individuals acting informally: 

– carers 

– relatives 

– partners 

– neighbours or friends 

– staff. 

● Those prescribed by legislation, such as Independent Mental Health 

Advocates and Independent Mental Capacity Advocates 

● Those provided by schemes run by local authorities, the NHS and 

charities. 



An understanding between two or more individuals or entities about 

enforceable rights and duties regarding their past or future performances 

and consideration. While an agreement usually leads to a written contract, 

it can also be recorded in different ways and may also be spoken, rather 

than written. 

Equipment or items that are crucial to the maintenance of fully 

independent, or partially independent, living. 

Alert letters Leafl ets sent out by bodies with information about specifi c problems that 

have arisen, or to warn that there may be a problem, for example a drug 

recall or an alert about an equipment fault. 

Algorithm A procedure that involves a fi nite series of sequential steps, used to fi nd 

the solution to a specifi c problem or to complete a specifi ed task. 

Balanced diet A diet that contains adequate amounts of all the necessary nutrients for 

maintaining or improving health. 

Behaviour that 

challenges 

Unusual or out-of-character behaviour that is attributable to mental ill 

health or a temporary emotional disturbance. 


205

Appendix A 

Bind over A person accused of an offence may be bound over to appear at a court, or 

to be of good behaviour, or to keep the peace. If they refuse to accept a 

bind over, the person may be committed to prison. A bind over is not a 

conviction and does not go onto a personal criminal record. 

Capacity 

(including 

concepts of 

competencies) 

Care 

programme 

approach 

The ability by someone to make a specifi c decision for himself or herself in 

a given situation. It is assumed that anyone aged 16 or over has capacity 

unless proven otherwise. 

There are no degrees of capacity: either a person has capacity or does not. 

Children under the age of 16 are assumed not to have capacity unless they 

have suffi cient understanding and intelligence to enable them to 

understand fully what is proposed. 

Capacity is defi ned by the Mental Capacity Act 2005 as: 

“People who lack capacity: 

(1) For the purposes of this Act, a person lacks capacity in relation to a 

matter if at the material time he is unable to make a decision for 

himself in relation to the matter because of an impairment of, or a 

disturbance in the functioning of, the mind or brain. 

(2) It does not matter if the impairment or disturbance is permanent or 

temporary. 

(3) A lack of capacity cannot be established merely by reference to: 

(a) A person’s age or appearance, or 

(b) A condition of his, or an aspect of his behaviour, which might lead 

others to make unjustifi ed assumptions about his capacity.” 



The process that providers of mental health care use to coordinate the 

care, treatment and support for people who have mental health needs. 

Carer Carers look after family, partners or friends in need of help because they 

are ill, frail or have a disability. The care they provide is unpaid. 

Carers include young carers. 

The term does not include paid care workers or people who undertake 

voluntary work. 




Carry on To provide, run or manage the provision of a regulated activity. 


Glossary 

Child/children The Children Act 1989 and the Children Act 2004 defi ne a child as being a 

person up to the age of 18 years. However, the Children Act 2004 states 

that safeguarding, protection and cooperation between services may, in 

certain circumstances, be continued through to a young person’s 19th 

birthday or beyond. 

Commissioner A person with responsibility for buying services from service providers in 

either the public, private or voluntary sectors. 

Commissioners 

of services 

Organisations that buy services on behalf of the people living in the area 

that they cover. This may be for a population as a whole, or for individuals 

who need specifi c care, treatment and support. For the NHS, this is done 

by primary care trusts and for social care by local authorities. 

Competency The required level of skills and knowledge for a particular task. 

Complaint An expression of dissatisfaction with something. This can relate to any 

aspect of a person’s care, treatment or support and can be expressed orally, 

in gesture or in writing. 

Compliance Agreement, assent or submission with defi ned requirements. 

Consent A person’s agreement to, or permission for, a proposed action, particularly 

any form of examination, care, treatment or support. 

Controlled 

drug 

Professionals have their own codes of practice that indicate how the 

consent they need from people who use services should be managed. 

In our guidance, we recognise that the consent of a person who uses 

services can involve another person, and that it can be obtained, given and 

recorded in different ways. 

One of a group of medicines that have the potential for abuse. For this 

reason, they are “controlled” by the Misuse of Drugs Act 1971. Many 

controlled drugs are essential to modern clinical care, treatment and 

support. They include narcotics, such as morphine and diamorphine, that 

are used in a wide variety of clinical treatments, for example relieving acute 

pain after a heart attack or fracture, relieving chronic pain, treating drug 

dependence and in anaesthesia. 

Culture Learned attitudes, beliefs and values that defi ne a group or groups of 

people. 

207

Appendix A 

Dignity Dignity is concerned with how people feel, think and behave in relation to 

the worth or value that they place on themselves and others. To treat 

someone with dignity is to treat them as being of worth and respect them 

as a valued person, taking account of their individual views and beliefs. 

Discharge The point at which a patient leaves hospital to return home or be 

transferred to another service, or the formal conclusion of a service 

provided to a person who uses services. 

Employed The employment under a contract of service, an apprenticeship, a contract 

for services or otherwise than under a contract, including a carer agreement 

and the grant of practising privileges. 

It includes: 

● Contracted staff 

● Temporary staff 

● Bank staff 

● Practitioners working under practising privileges 

● Volunteers 

● Students and learners 

● Contractors. 

End of life The last phase of a person’s life, when a judgement has been made by an 

appropriately qualifi ed person that the person has an advanced, 

progressive, incurable illness, or that the person’s death is imminent. 

End of life care The care, treatment and support that is provided to enable a person with 

advanced, progressive, incurable illness to live as well as possible before 

they die. End of life care also covers the management of pain and other 

symptoms, and the provision of psychological, social, spiritual and practical 

support, and support for the family into bereavement. 

Enforcement 

action 

Action taken to cancel, prevent or control the way a service is delivered 

using the range of statutory powers available to the Care Quality 

Commission. It can include action taken in respect of services that should 

be, but are not, registered. 


Glossary 

Equipment Machines and medical devices used to help, prevent, treat or monitor a 

person’s condition or illness. The term may also be used to refer to aids that 

may support a person’s care, treatment, support, mobility or independence, 

for example, a walking frame, hoist, or furniture and fi ttings. It excludes 

machinery or engineering systems that are physically affi xed and integrated 

into the premises. 

Examination Examination includes undertaking tests such as an x-ray or taking a blood 

sample to determine a diagnosis and treatment plan, or whether further 

tests are needed, or if a person needs to be referred for more in-depth or 

specialist tests or treatment. 

Experience Experience can refer to the broad effects that care, treatment or support 

can have on a person, including their thoughts and feelings about the care, 

treatment and support they have received, how they interact with staff and 

others, or any wider impact on their life and those around them. 

It can also refer to the experience a health or social care professional has of 

delivering a specifi c type of care, treatment or support. It often includes 

aspects of knowledge and skill, as well as taking account of the length of 

time they have been undertaking certain activities or the number of times 

they have performed an activity. 

Expert bodies Professional organisations that develop, issue and design technical and 

operational standards relating to specialist areas. 

General 

practitioner 

(GP) 

Handling 

(medicines) 

Health action 

plan 

A medical practitioner who provides primary care and specialises in family 

medicine. General practitioners treat acute and chronic illnesses and 

provide preventative care and health education for all ages and genders. 

The safe and secure, storage, selection, preparation, giving or 

administering, and safe disposal, of medicines. 

A guide to a person’s health that may be developed in any healthcare 

setting. It describes the person’s health and the best ways to support them 

to get the right treatment and healthcare. 

Healthcare The preservation of mental and physical health by preventing or treating 

illness through services offered by the health professions, including those 

working in social care settings. 

Healthcareassociated 

infection 

An avoidable infection that occurs as a result of the healthcare that a 

person receives. 


209

Appendix A 

Healthcare 

professional 

Individuals regulated and/or licensed to provide some type of healthcare. 

Health status The current state of a person’s health. It includes the status of their 

wellness, fi tness, and any underlying diseases or injuries. 

Holistic About the whole person, including all their needs and all aspects of their life. 

Homely remedy A medicine that can be bought without a prescription to treat a minor 

ailment. 

Hospice An organisation or agency that provides multidisciplinary and personcentred 

palliative care for people with an advanced, progressive, incurable 

disease. Care, treatment and support may be provided to the person 

through a range of services such as inpatient care, day care, community 

and social care, home care, outpatient appointments, sitting services, 

respite care and bereavement support, when curative treatment is no 

longer an option. 

Human rights The basic rights and freedoms contained in the European Convention on 

Human Rights. The Human Rights Act 1998 means that these should be 

available to everyone, regardless of their age, nationality, race, ethnicity, 

gender or religion and beliefs. It is an offence for a public body to breach 

any person’s human rights, and under the Health and Social Care Act 2008, 

“public body” includes any provider that supplies accommodation together 

with nursing or personal care on behalf of a local authority. 

Implied 

consent 

Independent 

doctor 

Independent 

healthcare 



A form of consent that is not expressly granted by a person, but rather 

inferred from a person’s actions and the facts and circumstances of a 

particular situation (or in some cases, by a person’s silence or inaction). 

The assumed agreement is that the person would approve a course of 

action if asked in a given situation, but is not presently able to be asked. 

Medically qualifi ed doctors who are actively practising, but who do not 

hold a post in the NHS. 

Private, voluntary and not-for-profi t healthcare organisations that are not 

part of the NHS. 

Intimidation To scare, frighten or coerce, especially with threats. 


Glossary 

Medical device Any instrument, apparatus, appliance, material or other article (whether 

used alone or in combination), including the software necessary for its 

proper application, intended by the manufacturer to be used for people for 

the purpose of: 

● Diagnosis, prevention, monitoring, treatment or alleviation of disease. 

● Diagnosis, monitoring, alleviation of or compensation for an injury or 

disability. 

● Investigation, replacement or modifi cation of the anatomy or of a 

physiological process. 

● Control of conception, 

and which does not achieve its physical intended action on the human 

body by pharmacological, immunological or metabolic means, but may be 

assisted in its function by such means. 

Medicine A substance or substances administered for the purpose of modifying, 

controlling, treating or diagnosing a medical condition, disease or illness. 

Nutritional 

assessment 

Nutritional 

screening 

Nutritional 

status 

A detailed, specifi c and in-depth evaluation of nutritional status, typically 

undertaken by a person with nutritional expertise (for example, a dietician, 

a clinician with a specialist interest or a nurse specialist), so that a specifi c 

dietary plan can be drawn up and implemented. It is often used for more 

complicated nutritional problems. 

A quick, simple and general procedure used by nursing, medical, or other 

healthcare or social care staff, often at fi rst contact with the person using 

the service, to detect those at risk of poor nutrition. This allows a clear plan 

of action to be developed and implemented. It should be an integral part 

of the initial assessment of the person using the service on their admission, 

or on receipt of care, treatment and support when they begin to use the 

service. 

A person’s physiological state that results from the relationship between 

nutrient intake and requirements. and from the body’s ability to digest, 

absorb and use these nutrients. 

Palliative care The active, holistic care of people who use services with advanced 

progressive illness. Management of pain and other symptoms, and 

provision of psychological, social and spiritual support, is paramount. 

The goal of palliative care is to achieve the best quality of life for people 

who use services and their families. Many aspects of palliative care are also 

applicable earlier in the course of the illness, in conjunction with other 

treatments. 


211

Appendix A 

Parent A person holding a legally recognised parental responsibility. 

People who use 

services 

A person who receives services provided in the carrying on of a regulated 

activity. This is the defi nition of “service user” provided in the Health and 

Social Care Act 2008 (Regulated Activities) Regulations 2010. 



Personalised Where the person using the service leads, with choice being the defi ning 

principle. 

Person-centred Putting the person who uses services at the centre of their care, treatment 

and support, ensuring that everything that is done is based on what is 

important to that person from their own perspective. 

Plan of support A written and agreed plan to provide support to a worker in the discharge 

of their responsibilities, and for people who use services to know what to 

expect of their care. A plan of support should be agreed between the 

worker and others involved in supporting them – these may include the 

employer, employee representatives, occupational health professionals and 

others. 

Polypharmacy The use of multiple medicines to treat a person, without appropriate review 

to ensure that they are all necessary for effective treatment. 

Practising 

privileges 

The right granted to a healthcare professional to practise or provide care, 

treatment or support to people using independent healthcare services. The 

right to practise is based on similar principles as an employment contract, 

without the two parties entering into a formal contract of employment. 

Practising privileges are granted after the same checks have been made on 

a person as on anyone that the service directly employs. By accepting 

practising privileges, the healthcare professional accepts to be bound by 

the policies, protocols, systems and governance arrangements set up by the 

provider of the service. 

Premises Any building or other structure, including any machinery or engineering 

systems that are physically affi xed and integral to such building or 

structure, or a vehicle. 

Prescribing To order the use of a medicine or other treatment by someone authorised 

to prescribe. 


Privacy and 

dignity 

Professional 

body 


Glossary 

To respect a person’s privacy is to recognise when they wish and need to be 

alone (or with family or friends), and protected from others looking at 

them or overhearing conversations that they might be having. It also 

means respecting their confi dentiality and personal information. To treat 

someone with dignity is to treat them as being of worth and respect them 

as a valued person, taking account of their individual beliefs. 

An organisation that exists to further a profession and to protect both the 

public interest, by maintaining and enforcing standards of training and 

ethics in their profession, and the interest of its professional members. 

Public interest There is no single defi nition of public interest. It includes, but is not 

confi ned to: 

Quality 

monitoring 

● Exposing or detecting crime. 

● Exposing signifi cantly anti-social behaviour. 

● Exposing corruption or injustice. 

● Disclosing signifi cant incompetence or negligence. 

● Protecting people’s health and safety. 

● Preventing people from being misled by some statement or action of an 

individual or organisation. 

● Disclosing information that allows people to make a signifi cantly more 

informed decision about matters of public importance. 

There is also a public interest in freedom of expression itself. When 

considering what is in the public interest, we also need to take account of 

information already in the public domain or about to become available to 

the public. 

A continuous system of monitoring to ensure that local quality measures 

are effective. Quality monitoring is part of quality assurance. 

213

Appendix A 

Reasonable 

adjustments 

The duty to make reasonable adjustments, as set out in the Disability 

Discrimination Act 1995, aims to ensure that people with a disability are 

not disadvantaged. There are three parts to the duty: 

● A duty to take reasonable steps to change a practice, policy or procedure 

that makes it impossible or unreasonably diffi cult for people with a 

disability to receive any benefi t. 

● A duty to take reasonable steps to remove, alter, or provide an 

alternative method to, a physical feature that makes it impossible or 

unreasonably diffi cult for people with a disability to receive any benefi t. 

● A duty to take reasonable steps to provide an additional aid or service 

where it would enable people with a disability to receive any benefi t. 

Record A formal written report or statement of facts, events or information, usually 

collected over a fairly long period of time. The act of maintaining individual 

records is called recording. 

Resources The things needed to carry out a task or a piece of work. Resources can 

include appropriately qualifi ed staff, suitable buildings and suffi cient 

equipment. 

Restraint The Mental Capacity Act 2005 defi nes restraint as: 

● Physical restraint – holding someone, moving a person or blocking their 

movement. 

● Mechanical restraint – use of equipment. 

● Chemical restraint – use of medication. 

● Environmental restraint. 

● Technological surveillance – use of tags, CCTV, door alarms or pressure 

pads. 

● Psychological restraint – constant commands. 

Risk The probability of an issue occurring, related to a particular condition or 

treatment. Also the conclusion of considering the likelihood of an adverse 

event occurring and, if it does occur, how severe the consequences are 

likely to be. 

The risk may come directly from the condition itself or indirectly from the 

process or method involved in the treatment or application. Risk does not 

mean bad things will happen. It allows people to make decisions about the 

world in which they live and the choices they have to make, because it is a 

balanced judgement of danger. 


Risk 

assessment 

The process of identifying all the risks to and from an activity, and 

assessing the potential impact of each risk. 

Safeguard To protect and promote the welfare of people: 

● Protecting people from abuse or neglect. 

● Preventing impairment of people’s health or development. 


Glossary 

● Ensuring that people receive care, treatment and support in 

circumstances consistent with the provision of safe and effective care, 

treatment and support. 

Safeguarding Ensuring that people live free from harm, abuse and neglect and, in doing 

so, protecting their health, wellbeing and human rights. Children, and 

adults in vulnerable situations, need to be safeguarded. For children, 

safeguarding work focuses more on care and development; for adults, 

on independence and choice. 

Social and 

cultural values 

Social and cultural values relate to a way of life. All societies have a culture, 

or common way of life, that includes: 

● Language – the spoken word and other communication methods. 

● Customs – rites, rituals, religion and lifestyle. 

● Shared system of values – beliefs and morals. 

● Social norms – patterns of behaviour that are accepted as normal and 

right. (These can include dress and diet.) 

The different cultures in society refl ect the richness of cultural diversity, 

where different people live and work together, but retain their individual 

identity. 

Social care Social care includes all forms of personal care and other practical assistance 

provided for people who by reason of age, illness, disability, pregnancy, 

childbirth, dependence on alcohol or drugs or any other similar 

circumstances, are in need of such care or other assistance. 

For the purposes of the Care Quality Commission, it only includes care 

provided for, or mainly for, people over 18 years’ old in England. We 

sometimes refer to this as adult social care. 

215

Appendix A 

Specialist 

techniques for 

nutrition 

Sometimes it is not be possible for people, such as those with acute 

swallowing problems or anorexia or those who have had abdominal surgery, 

to consume food orally. In these cases, it may be necessary to provide 

nutrition artifi cially by inserting a tube or other device. There are various 

methods of doing this, for example naso-gastric tube, percutaneous 

endoscopic gastrostomy (PEG) feed, and enteral and parenteral feeding. 

These techniques can be prescribed only by a specialist such as a dietician 

and undertaken by a trained healthcare professional. 

Staff The entire group of people employed for the purposes of carrying on a 


Supervision A process to guide, support and assist people who provide services to carry 

out their duties and assigned tasks, so as to achieve the planned outcome. 

Third party A person or organisation other than the principals who are involved in a 

transaction or direct provision of a service. 

Timely At the right, or at a suitable, moment. 

Volunteer An unpaid member of staff. A person who gives their time willingly in 

return for no payment in money or kind. 

Welfare A person’s state or condition, taking into account their physical, social and 

fi nancial situation. A person’s welfare will also take account of their 

emotional and spiritual states. 

Without delay As soon as it is reasonably practicable to do so. 


Appendix B: Schedule of Applicable Publications 

Appendix B: Schedule of Applicable 

Publications 

In the prompts for some of the regulations, we include the following 

statement: 

“People who use services benefi t from a service that takes into account 

relevant guidance, including that from the Care Quality Commission’s 

Schedule of Applicable Publications.” 

For each outcome where the above statement appears, we set out below 

the documents that we intend to consider. Providers should refl ect the key 

expectations of these publications for their service, as they relate to the 

essential standards of quality and safety. 

For some publications, these expectations are different for different types of 

service. For example: 

NHS Information Governance: Guidance on Legal and Professional 

Obligations (DH, 2007) 

● This publication is listed in this Schedule under outcome 21 (Records). 

● It provides information about the range of legal and professional 

obligations that limit, prohibit or set conditions in respect of the 

management, use and disclosure of information. It focuses mainly on the 

impact of these provisions for NHS information, but also includes some 

social care information. It may also include useful guidance about these 

laws for independent healthcare providers. 

● Therefore, the expectations within this publication are different for 

different types of provider, and providers should be aware what this 

publication means for them. 

This Schedule does not include any acts of Parliament or underpinning 

regulations enacted by Parliament, as legislation is enforceable in its own 

right and there is provision under the Health and Social Care Act 2008 for us 

to take other enactments into account in our work. 


217

Appendix B 

Abbreviations used: 

DCSF = Department for Children, Schools and Families 

DH = Department of Health 

MHRA = Medicines and Healthcare products Regulatory Agency 

NICE = National Institute for Health and Clinical Excellence 

NPSA = National Patient Safety Agency 

NTA = National Treatment Agency for Substance Misuse 

Outcome 1 Respecting and involving people who use services 

● The NHS Constitution (DH, 2009) 

● Confi dentiality: NHS code of practice (DH, 2003) 

● Relevant national strategies, national service frameworks, and nationally agreed policy 

guidance and recommendations about involving people published by the Department of Health 

and other Government departments, including: 

– Human Rights in Health Care – A Framework for Local Action (DH) 

– Valuing People: a new strategy for learning disability for the 21st century (HM Government, 

2001) 

– Valuing People Now: a new three-year strategy for people with learning disabilities – Making 

it happen for everyone (HM Government, 2009) 

– Real involvement: working with people to improve services (DH, 2008) 

– Independence, Choice and Risk: A Framework for Supported Decision Making (DH, 2007) 

– Refocusing the care programme approach: Policy and positive practice guidance (DH, 2008) 

● Guide to the public sector equalities duties (Equality and Human Rights Commission, 2009) 

● Being open – communicating patient safety incidents with patients and their carers (NPSA, 

2006) 

● Care Planning Practice Guide (NTA, 2006) 


Outcome 2 Consent to care and treatment 


● Reference guide to consent for examination or treatment (DH, 2001) 

Schedule of Applicable Publications 

● Good practice in consent: achieving the NHS plan commitment to patient centred consent 

practice (Health Service Circular HSC 2001/023) 

● Seeking Consent: working with children (DH, 2001) 

● Research governance framework for health and social care: Second edition (DH, 2005) 

● Procedures for the Approval of Independent Sector Places for the Termination of Pregnancy 

(DH) 

● Relevant guidance and codes of conduct relating to consent published by professional 

registration councils such as the General Medical Council, Nursing & Midwifery Council, 

General Social Care Council and the Health Professions Council 

● Mental Health Act Code of Practice (2007) 

● Mental Capacity Act Code of Practice (2008) 

Outcome 3 Fees 

● Offi ce of Fair Trading: Guidance on unfair terms in care home contracts 

● Offi ce of Fair Trading: Guidance on unfair contract terms 

● General Medical Council code of conduct 


219

Appendix B 

Outcome 4 Care and welfare of people who use services 


● Mental Capacity Act Code of Practice (2007) 



2006) 

● Mental Health Act Code of Practice (2008) 

● Care Planning Practice Guide (NTA, 2006) 

● National strategies, national service frameworks and white papers, and nationally agreed policy 

guidance published by the Department of Health and other Government departments, 

including: 

– National Service Framework for Mental Health (DH, 1999) 

– National Service Framework for Older People (DH, 2001) 

– Valuing People: a new strategy for learning disability for the 21st century (HM Government, 

2001) 

– Diabetes National Service Framework (DH, 2003) 

– National Service Framework for children, young people and maternity services (DH & 

Department for Education and Skills, 2004) 

– Choosing Health: Making healthy choices easier (DH, 2004) 

– National Service Framework for Renal Services (DH, 2004) 

– National Service Framework for Long Term Conditions (DH, 2005) 

– Cancer Reform Strategy (DH, 2007) 

– National Framework for NHS Continuing Health care and NHS funded Nursing Care (DH, 

2007) 

– National Stroke Strategy (DH, 2008) 

– End of Life Care Strategy (DH, 2008) 

– Living well with dementia: A National Dementia Strategy (DH, 2009) 

– Healthy Lives brighter futures: The children strategy for children and young people’s health 

(DH, 2009) 




Outcome 4 (cont) Care and welfare of people who use services 


● Relevant policy and implementation guidance and recommendations about good practice 

published by the Department of Health. Including: 

– Refocusing the care programme approach: Policy and positive practice guidance (DH, 2008) 

– Mental Health Policy Implementation Guide: Adult Acute Inpatient Care Provision (DH, 

2002) 

– Mental Health Policy Implementation Guide: National Minimum Standards for General Adult 

Services in Psychiatric Intensive Care Units and Low Secure Environments (DH, 2002) 

– The acutely or critically sick or injured child in the district general hospital: A team response 

(DH, 2006) 

– Drug misuse and dependence: UK guidelines on clinical management (DH, 2007) 

– DH Procedures for the Approval of Independent Sector Places for the Termination of 

Pregnancy 

– DH Guidance on the Establishment and Use of Diagnostic Reference Levels 

– DH IRMER Guidance and Good Practice Notes 

● Relevant evidence-based guidance about good practice and alerts published by expert and 

professional bodies, including: 

– Equality and Human Rights Commission 

– Joint Committee on Human Rights 

– The National Treatment Agency for Substance Misuse 

– Health Service Ombudsman 

– National Institute for Health and Clinical Excellence 

– Social Care Institute for Excellence 

– National Patient Safety Agency 

– Medicines and Healthcare products Regulatory Agency 

– Health Protection Agency 

– Administration of Radioactive Substances Advisory Committee 

– Medical and other clinical royal colleges, faculties and professional associations 


221

Appendix B 

Outcome 5 Meeting nutritional needs 

● Nutrition support in adults (CG 32, NICE, 2006) 

● Nutrition Action Plan (DH and Nutrition Summit stakeholders, 2007) 

● Relevant evidence-based guidance about nutrition in health and social care settings published 

by expert and professional bodies 

Outcome 6 Cooperating with other providers 


● Records management: NHS code of practice (DH, 2006) 

● Guidance on the Health Act Section 31 partnership agreements (DH, 1999) 

● Discharge from hospital pathway, process and practice (DH, 2003) 

● Information security management: NHS code of practice (DH, 2007) 

● Relevant national strategies, national service frameworks, white papers, and nationally agreed 

policy guidance and recommendations published by the Department of Health and other 

Government departments where they include guidance about working in partnership, 

including: 

– The NHS Emergency Planning Guidance (DH, 2005), and associated supplements (DH, 

2005, 2007) 

– Pandemic Infl uenza: A National Framework for Responding to an Infl uenza Pandemic (DH, 

2007) 

– Every Child Matters (HM Government, 2003) 



– Creating strong, safe and prosperous communities. Statutory Guidance (HM Government, 

2008) 

– Green light for mental health: How good are your mental health services for people with 

learning disabilities; A service toolkit (DH, 2004) 

– Dual diagnosis in mental health inpatient and day hospital settings (DH, 2006) 

– Everybody’s business: A service development guide (DH & Care Services Improvement 

Partnership, 2005) 

– DCSF guidance on information sharing 



Outcome 7 Safeguarding people who use services from abuse 

● No secrets: Guidance on developing and implementing multi-agency policies and procedures to 

protect vulnerable adults from abuse (DH and Home Offi ce, 2000) 

● Working together to safeguard children (HM Government, 2006) and supplementary guidance 

published by government departments 

● Every Child Matters (HM Government, 2003) 

● Statutory Guidance on making arrangements to safeguard and promote the welfare of children 

under section 11 of the Children Act 2004 (DCSF, 2007) 

● Safeguarding Adults: A National Framework of Standards for good practice and outcomes in 

adult protection work (Association of Directors of Adult Social Services, 2005) 

● Deprivation of Liberty Safeguards: A guide for hospitals and care homes (DH, 2009) 

● Guidance for restrictive physical interventions: How to provide safe services for people with 

learning disabilities and autistic spectrum disorder (DH, 2002) 

● What to do if you’re worried a child is being abused (HM Government, 2006) 

● Healthy Lives brighter futures: The children’s’ strategy (DH, 2009) 

● Information Sharing: Guidance for practitioners and managers (DCSF, 2008) 

● Statement on the duties of doctors and other professionals in investigations of child abuse 

(DCSF and DH, 2007) 

● Mental Health Act Code of Practice (DH, 2008) 

● Mental Capacity Act Code of Practice (DH, 2007) 

● Violence: The short term management of violent/disturbed behaviour in in-patient psychiatric 

and emergency departments (CG25, NICE, 2005) 

● Guidance on when to suspect child maltreatment (CG89, NICE, 2009) 

● Services for people with learning disabilities and challenging behaviour or mental health needs 

– Mansell report: revised edition (DH, 2007) 


223

Appendix B 

Outcome 9 Management of medicines 

● Relevant evidence-based guidance and alerts about medicines management and good practice 

published by appropriate expert and professional bodies, including: 




– Department of Health 

– Royal Pharmaceutical Society of Great Britain (RPSGB) 



● The safe and secure handling of medicines: a team approach (RPSGB, 2005) 

● Safer management of controlled drugs: Guidance on strengthened governance arrangements 

(DH, 2007) 

● Safer management of controlled drugs: Guidance on standard operating procedures for 

controlled drugs (DH, 2007) 

● The handling of medicines in social care (RPSGB, 2007) 



Outcome 10 Safety and suitability of premises 


● All currently valid Health Technical Memoranda (HTMs) published by the Department of Health 

● All currently valid Health Building Notes (HBNs) published by the Department of Health 

● Legionnaires Disease: The control of legionella bacteria in water systems, approved code of 

practice and guidance (Health and Safety Executive, 2000) 

● Controlling legionella in nursing and residential care homes (Health and Safety Executive, 

1997) 

● Guidance on Manual Handling operations Regulations (Health and Safety Executive, 2004) 

● Alerts, rapid response reports, guidance and directives about all aspects of healthcare and 

social care premises published by: 


–DH 

– Secretary of State 

– Health and Safety Executive 

– Department of Environmental Health 

– Home Offi ce 



– NHS Estates 


– Care Services Improvement Partnership 

– Professional Royal Colleges and other recognised professional bodies 

● A professional approach to managing security in the NHS (NHS Security Management Service, 

2003) 

● Safety, privacy and dignity in mental health units. Guidance in mixed sex accommodation for 

mental health services (NHS Executive, 2000) 

● Implementation Criteria for Recommended Specifi cation: Adult Medium Secure Units (Quality 

Network for Forensic Mental Health Services, 2007) 

● Environmental principles for medium secure accommodation (Health Offender Partnerships, 2008) 

● The NHS constitution (DH, 2009) 

● Guidance notes for Dental Practitioners on the Safe Use of X-ray Equipment published by the 

National Radiation Protection Board 


225

Appendix B 

Outcome 11 Safety, availability and suitability of equipment 

● MHRA DB2008(03) Guidance on the safe use of lasers, IPL systems and LEDs 

● MHRA DB 2006 (4) Single-use Medical Devices: Implications and Consequences of Reuse 

(MHRA, 2006) 

● MHRA DB 2006(5) Managing Medical Devices: Guidance for health care and social care 

organisations (MHRA, 2006) 

● Safety alerts, rapid response alerts, guidance and directives relating to equipment published by 

expert and professional bodies including: 

– National Institute of Clinical Excellence 



– Royal Pharmaceutical Society of Great Britain 

–DH 

– Product manufacturers 

● DH IRMER Guidance and Good Practice Notes 

● Mental Health Act 1983 and Mental Health Act Code of Practice (DH, 2008 relating to 

seclusion facilities) 


Outcome 12 Requirements relating to workers 

● NHS employment check standards published by NHS Employers 


● Code of practice for the international recruitment of health care professionals (DH, 2004) 

● The Health care Professionals Alert Notices Directions 2006 (DH, 2006) 

● Relevant guidance and codes of conduct and practice about professional registration and 

qualifi cations published by professional registration councils and professional bodies including: 

– General Medical Council 

– Nursing and Midwifery Council 

– Health Professional Council 

– General Dental council 

– General Social Care Council 

– Royal Pharmaceutical Society of Great Britain 


● CRB Code of Practice 

● Safeguarding Vulnerable Groups Act 2006 

● Protection of vulnerable adults scheme (POVA) 

● ISA Referral Guidance (Independent Safeguarding Authority, 2009) 



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Appendix B 

Outcome 13 Staffi ng 

● Relevant guidance about staffi ng levels and skills mix published by professional registration 

councils and relevant expert and professional bodies, including: 

– Skills for Care 

– Skills for Health 


– Nursing and Midwifery Council 

– National Health Service 

– British Medical Association 

– Royal College of Nursing 



– Health Professional Council 

– General Dental Council 

–DH 



– NHS Employers 

– Health and Safety Executive 


● National service frameworks and national strategies published by the Department of Health 

and other Government departments where they include guidance about staffi ng levels and 

skills mix. 

● DH – Procedures for the Approval of Independent Sector Places for the Termination of 

Pregnancy 


Outcome 14 Supporting workers 


● Relevant guidance and curricula about supporting workers published by relevant expert and 

professional bodies, including: 

– Skills for Care 

– Skills for Health 

– NHS Employers 





● NHS promoting safer and therapeutic services October 2005; published by the NHS Security 

management Service 

● Assuring the Quality of Medical Appraisal July 2005; a report published by the NHS Clinical 

Governance Support Team 

● NHS Appraisal; Appraisal for consultants working in the NHS 

● Secretary of State Directions on work to tackle violence against staff and professionals who 

work in or provide services to the NHS (DH, 2003) 

● Published guidance from the Health & Safety Executive 



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Appendix B 

Outcome 16 Assessing and monitoring the quality of service provision 

● Listening, improving, responding: a guide to better customer care (DH, 2009) 


● Relevant guidance, national reports and codes of conduct about risk management, monitoring 

quality and audit published by expert and professional bodies, including: 


– Nursing & Midwifery Council 


– General Dental Council 

– Health Professions Council 


■ National Confi dential Enquiry into Patient Outcomes and Death 

■ Confi dential Enquiries into Maternal and Child Health 


– NHS Litigation Authority 


Outcome 17 Complaints 

● NHS Constitution (DH, 2009) 

● The Principles of Good Complaint Handling (Parliamentary and Health Service Ombudsman, 

2008) 

● Listening, improving, responding: a guide to better customer care (DH, 2009) 

● NHS Litigation Authority guidance about complaints 


2009) 


Outcome 21 Records 


● Confi dentiality: NHS code of practice (DH, 2003) 

● Caldicott Guardian Manual 2006 (DH, 2006) 

● Records management: NHS code of practice (DH, 2006), 

● Information security management: NHS code of practice (DH, 2007) 


● NHS Information Governance: Guidance on Legal and Professional Obligations (DH, 2007) 

● Relevant professional guidance and codes of conduct and practice relating to record keeping 

published by professional bodies and registration councils including the General Medical 

Council, Nursing & Midwifery Council, General Social Care Council, BMA, RCN, Health 

Professional Council, Royal College of Physicians and the Academy of Medical Royal Colleges 

● DH – Procedures for the Approval of Independent Sector Places for the Termination of 

Pregnancy 

● Codes of practice published by the Information Commissioner 


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Appendix C 

STATUTORY INSTRUMENTS 

2010 No. 781 

NATIONAL HEALTH SERVICE, ENGLAND 

SOCIAL CARE, ENGLAND 

PUBLIC HEALTH, ENGLAND 

The Health and Social Care Act 2008 (Regulated Activities) 


Made - - - - 15th March 2010 

Coming into force - - 1st April 2010 

The Secretary of State makes the following Regulations in exercise of the powers conferred by 

sections 8(1), 20(1) to (5), 35, 86(2) and (4), 87(1) and (2) and 161(3) and (4) of the 

Health and Social Care Act 2008(a). 

In accordance with section 20(8) of the Act, the Secretary of State has consulted such persons as 

he considers appropriate. 

A draft of these Regulations was laid before Parliament in accordance with section 162(3) of the 

Health and Social Care Act 2008 and approved by resolution of each House of Parliament. 

Citation and commencement 

PART 1 

GENERAL 

1. These Regulations may be cited as the Health and Social Care Act 2008 (Regulated 

Activities) Regulations 2010 and come into force on 1st April 2010. 

Interpretation 

2. In these Regulations— 

“the Act” means the Health and Social Care Act 2008; 

“the 1983 Act” means the Mental Health Act 1983(b); 

“the 2006 Act” means the National Health Service Act 2006(c); 

(a) 2008 c. 14. “Prescribed” and “regulations” are defined in section 97(1) of the Act. 

(b) 1983 c.20. 

(c) 2006 c.41. 




“the 2001 Order” means the Health Professions Order 2001(a); 

“adult placement carer” means an individual who, under the terms of a carer agreement, 

provides, or intends to provide, personal care for service users together with, where 

necessary, accommodation in the individual’s home; 

“adult placement scheme” means a scheme carried on (whether or not for profit) by a local authority 

or other person for the purposes of— 

(a) recruiting and training adult placement carers; 

(b) making arrangements for the placing of service users with adult placement carers; and 

(c) supporting and monitoring placements; 

“carer agreement” means an agreement entered into between a person carrying on an adult 

placement scheme and an individual for the provision, by that individual, of personal care to a 

service user together with, where necessary, accommodation in the individual’s home; 

“chiropodist or podiatrist” means a person registered as such with the Health Professions 

Council pursuant to article 5 of the 2001 Order(b); 

“employment” means— 

(a) employment under a contract of service, an apprenticeship, a contract for services or 

otherwise than under a contract (including under a carer agreement); and 

(b) the grant of practising privileges, 

and “employed” and “employer” should be construed accordingly; 

“employment agency” and “employment business” have the same meanings as in the 

Employment Agencies Act 1973(c); 

“health care professional” means, except in paragraph 5 of Schedule 1, a person who is 

registered as a member of any profession to which section 60(2) of the Health Act 1999(d) 

applies; 

“hospital”, except in paragraphs 1(3)(d) and 6 of Schedule 1, has the same meaning as in section 

275 of the 2006 Act; 

“institution within the further education sector” has the same meaning as in section 91 of the 

Further and Higher Education Act 1992(e); 

“local anaesthesia” means any anaesthesia other than general, spinal or epidural anaesthesia, 

and also excludes the administration of a regional nerve block; 

“medical practitioner” means a registered medical practitioner(f); 

“nominated individual” must be construed in accordance with regulation 5(2); 

“nurse” means a registered nurse; 

“nursing care” means any services provided by a nurse and involving— 

(a) the provision of care; or 

(b) the planning, supervision or delegation of the provision of care, 

other than any services which, having regard to their nature and the circumstances in which 

they are provided, do not need to be provided by a nurse; 

“personal care” means— 

(a) S.I. 2002/254. 

(b) See the definition of “relevant professions” in Schedule 3, paragraph 1 of the 2001 Order as amended by S.I. 2004/2033, 

article 10(5)(b)(i). 

(c) 1973 c.35. See section 13(2) and (3). Section 13(2) was amended by the Employment Relations Act 1999 (c.26), Schedule 

7, paragraphs 1 and 7. 

(d) 1999 c.8. Section 60(2) was amended by the Health and Social Care Act 2008, Schedule 8, paragraph 1(3) and Schedule 15, 

Part 2 and by S.I. 2002/253 and the 2001 Order. 

(e) 1992 c.13. 

(f) The definition of “registered medical practitioner” in Schedule 1 to the Interpretation Act 1978 (c.30) has been substituted 

by S.I. 2002/3135, Schedule 1, paragraph 10 with effect from 16th November 2009. 


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Appendix C 

(a) physical assistance given to a person in connection with— 

(i) eating or drinking (including the administration of parenteral nutrition), 

(ii) toileting (including in relation to the process of menstruation), 

(iii) washing or bathing, 

(iv) dressing, 

(v) oral care, or 

(vi) the care of skin, hair and nails (with the exception of nail care provided by a chiropodist or 

podiatrist); or 

(b) the prompting, together with supervision, of a person, in relation to the performance of any of 

the activities listed in paragraph (a), where that person is unable to make a decision 

for themselves in relation to performing such an activity without such prompting and 

supervision; 

“practising privileges” means the grant, by a person managing a hospital, to a medical 

practitioner of permission to practise as a medical practitioner in that hospital; 

“premises” means— 

(a) any building or other structure, including any machinery or engineering systems which are 

physically affixed and integral to such building or structure; or 

(b) a vehicle; 

“registered manager” means, in respect of a regulated activity, a person registered with the 

Commission under Chapter 2 of Part 1 of the Act as a manager in respect of that activity, and 

“manage” should be construed accordingly; 

“registered person” means, in respect of a regulated activity, a person who is the service 

provider or registered manager in respect of that activity; 

“school” has the same meaning as in the Education Act 1996(a); 

“service provider” means, in respect of a regulated activity, a person registered with the 

Commission under Chapter 2 of Part 1 of the Act as a service provider in respect of that 

activity; 

“service user” means a person who receives services provided in the carrying on of a regulated 

activity; 

“treatment”, except in paragraph 6 of Schedule 1, includes— 

(a) a diagnostic or screening procedure carried out for medical purposes; 

(b) the ongoing assessment of a service user’s mental or physical state; 

(c) nursing, personal and palliative care; and 

(d) the giving of vaccinations and immunisations; 

“vulnerable adult” has the same meaning as in section 59 of the Safeguarding Vulnerable 

Groups Act 2006(b). 

Prescribed activities 

PART 2 

REGULATED ACTIVITIES 

3.—(1) Subject to paragraphs (3) to (8), for the purposes of section 8(1) of the Act, the activities 

specified in Schedule 1 are prescribed as regulated activities. 

(a) 1996 c.56; see section 4 for the meaning of “school”. Section 4 has been amended by the Education Act 1997 (c. 44), 

sections 51, 57(1) and (4) and Schedule 7, paragraphs 10(a) and (b) and Schedule 8, by the Education Act 2002 (c. 32), 

section 215(2) and Schedule 22, Part 3, and by the Childcare Act 2006 (c. 21), section 95(1), (2) and (3). 

(b) 2006 c. 47. Section 59 was amended by S.I. 2008/912, Schedule 1, paragraph 21 and by the Education and Skills Act 2008 

(c. 25), section 147(8). 




(2) An activity which is ancillary to, or is carried on wholly or mainly in relation to, a regulated 

activity shall be treated as part of that activity. 

(3) Subject to paragraph (4), until 1st October 2010, an activity is only a regulated activity if it is 

carried on by an English NHS body(a). 

(4) Where services involving, or connected with, the provision of social care are provided by an 

English NHS body which is registered as an establishment or agency under Part 2 of the Care 

Standards Act 2000(b) in relation to the provision of those services then, to the extent that those 

services are capable of being a regulated activity for the purposes of these Regulations, they are 

only a regulated activity with effect from 1st October 2010. 

(5) An activity is only a regulated activity if it is carried on in England. 

(6) In Schedule 1, in paragraph 10(1), the words “by an English NHS provider” shall cease to 

have effect on 1st April 2011. 

(7) Subject to paragraph (8), the activities specified in Schedule 2 are not regulated activities. 

(8) In Schedule 2— 

(a) paragraphs 3, 6 and 7 and, in paragraph 4, the words “and except where paragraph 3 

applies”, shall cease to have effect on 1st April 2012; and 

(b) paragraphs 9 and 11 shall cease to have effect on 1st April 2011. 

PART 3 

REQUIREMENTS RELATING TO PERSONS CARRYING ON OR MANAGING A 

REGULATED ACTIVITY 

Requirements where the service provider is an individual or partnership 

4.—(1) This regulation applies where a service provider (P) is an individual or a partnership. 

(2) P must not carry on a regulated activity unless P is fit to do so. 

(3) P is not fit to carry on a regulated activity unless P is— 

(a) an individual who carries on the regulated activity, otherwise than in partnership with 

others, and satisfies the requirements set out in paragraph (4); or 

(b) a partnership and each of the partners satisfies the requirements set out in paragraph (4); 

(4) The requirements referred to are that P or, where applicable, each of the partners is— 


(b) physically and mentally fit to carry on the regulated activity and has the necessary 


(c) able to supply to the Commission, or arrange for the availability of, information relating 

to themselves specified in Schedule 3. 

Requirement where the service provider is a body other than a partnership 

5.—(1) This regulation applies where the service provider is a body other than a partnership. 

(2) The body must give notice to the Commission of the name, address and position in the body 

of an individual (in these Regulations referred to as “the nominated individual”) who is employed 

as a director, manager or secretary of the body and who is responsible for supervising the 

management of the carrying on of the regulated activity by the body. 

(3) The registered person must take all reasonable steps to ensure that the nominated individual 

is— 

(a) See section 97(1) of the Act for the definition of “English NHS body”. 

(b) 2000 c. 14. 


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Appendix C 


(b) physically and mentally fit to supervise the management of the carrying on of the 

regulated activity and has the necessary qualifications, skills and experience to do so; and 

(c) able to supply to the registered person, or arrange for the availability of, the information 

specified in Schedule 3. 

Requirements relating to registered managers 

6.—(1) A person (M) shall not manage the carrying on of a regulated activity as a registered 

manager unless M is fit to do so. 

(2) M is not fit to be a registered manager in respect of a regulated activity unless M is— 


(b) physically and mentally fit to carry on the regulated activity and has the necessary 


(c) able to supply to the Commission, or arrange for the availability of, the information 

relating to themselves specified in Schedule 3. 

Registered person: training 

7.—(1) If the service provider is— 

(a) an individual, the individual must undertake; 

(b) a partnership, it must ensure that one of the partners undertakes; or 

(c) a body other than a partnership, it must ensure that the nominated individual undertakes, 

from time to time such training as is reasonably practicable and appropriate to ensure that there are 

the necessary experience and skills available for carrying on the regulated activity. 

(2) The registered manager must undertake from time to time such training as is appropriate to 

ensure that the manager has the experience and skills necessary for managing the carrying on of 


PART 4 

QUALITY AND SAFETY OF SERVICE PROVISION IN RELATION TO REGULATED 

ACTIVITY 

General 

8. A registered person must, in so far as they are applicable, comply with the requirements specified 

in regulations 9 to 24 in relation to any regulated activity in respect of which they are registered. 

Care and welfare of service users 

9.—(1) The registered person must take proper steps to ensure that each service user is protected 

against the risks of receiving care or treatment that is inappropriate or unsafe, by means of— 

(a) the carrying out of an assessment of the needs of the service user; and 

(b) the planning and delivery of care and, where appropriate, treatment in such a way as to— 

(i) meet the service user’s individual needs, 

(ii) ensure the welfare and safety of the service user, 

(iii) reflect, where appropriate, published research evidence and guidance issued by the 

appropriate professional and expert bodies as to good practice in relation to such care 

and treatment, and 




(iv) avoid unlawful discrimination including, where applicable, by providing for the 

making of reasonable adjustments in service provision to meet the service user’s 

individual needs. 

(2) The registered person must have procedures in place for dealing with emergencies which are 

reasonably expected to arise from time to time and which would, if they arose, affect, or be likely 

to affect, the provision of services, in order to mitigate the risks arising from such emergencies to 


Assessing and monitoring the quality of service provision 

10.—(1) The registered person must protect service users, and others who may be at risk, against 

the risks of inappropriate or unsafe care and treatment, by means of the effective operation of 

systems designed to enable the registered person to— 

(a) regularly assess and monitor the quality of the services provided in the carrying on of the 

regulated activity against the requirements set out in this Part of these Regulations; and 

(b) identify, assess and manage risks relating to the health, welfare and safety of service users 

and others who may be at risk from the carrying on of the regulated activity. 


(a) where appropriate, obtain relevant professional advice; 

(b) have regard to— 

(i) the complaints and comments made, and views (including the descriptions of their 

experiences of care and treatment) expressed, by service users, and those acting on 

their behalf, pursuant to sub-paragraph (e) and regulation 19, 

(ii) any investigation carried out by the registered person in relation to the conduct of a 

person employed for the purpose of carrying on the regulated activity, 

(iii) the information contained in the records referred to in regulation 20, 

(iv) appropriate professional and expert advice (including any advice obtained pursuant 

to sub-paragraph (a)), 

(v) reports prepared by the Commission from time to time relating to the registered 

person’s compliance with the provisions of these Regulations, and 

(vi) periodic reviews and special reviews and investigations carried out by the 

Commission in relation to the provision of health or social care, where such reviews 

or investigations are relevant to the regulated activity carried on by the service provider; 

(c) where necessary, make changes to the treatment or care provided in order to reflect 

information, of which it is reasonable to expect that a registered person should be aware, 

relating to— 

(i) the analysis of incidents that resulted in, or had the potential to result in, harm to a 

service user, and 

(ii) the conclusions of local and national service reviews, clinical audits and research projects 

carried out by appropriate expert bodies; 

(d) establish mechanisms for ensuring that— 

(i) decisions in relation to the provision of care and treatment for service users are taken 

at the appropriate level and by the appropriate person (P), and 

(ii) P is subject to an appropriate obligation to answer for a decision made by P, in 

relation to the provision of care and treatment for a service user, to the person 

responsible for supervising or managing P in relation to that decision; and 

(e) regularly seek the views (including the descriptions of their experiences of care and 

treatment) of service users, persons acting on their behalf and persons who are employed 

for the purposes of the carrying on of the regulated activity, to enable the registered person 


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Appendix C 

to come to an informed view in relation to the standard of care and treatment provided to 


(3) The registered person must send to the Commission, when requested to do so, a written 

report setting out how, and the extent to which, in the opinion of the registered person, the 

requirements of paragraph (1) are being complied with, together with any plans that the registered 

person has for improving the standard of the services provided to service users with a view to 

ensuring their health and welfare. 

Safeguarding service users from abuse 

11.—(1) The registered person must make suitable arrangements to ensure that service users are 

safeguarded against the risk of abuse by means of— 

(a) taking reasonable steps to identify the possibility of abuse and prevent it before it occurs; 


(b) responding appropriately to any allegation of abuse. 

(2) Where any form of control or restraint is used in the carrying on of the regulated activity, the 

registered person must have suitable arrangements in place to protect service users against the risk 

of such control or restraint being— 

(a) unlawful; or 

(b) otherwise excessive. 

(3) For the purposes of paragraph (1), “abuse”, in relation to a service user, means— 

(a) sexual abuse; 

(b) physical or psychological ill-treatment; 

(c) theft, misuse or misappropriation of money or property; or 

(d) neglect and acts of omission which cause harm or place at risk of harm. 


12.—(1) The registered person must, so far as reasonably practicable, ensure that— 

(a) service users; 

(b) persons employed for the purpose of the carrying on of the regulated activity; and 

(c) others who may be at risk of exposure to a health care associated infection arising from 

the carrying on of the regulated activity, 

are protected against identifiable risks of acquiring such an infection by the means specified in 

paragraph (2). 

(2) The means referred to in paragraph (1) are— 

(a) the effective operation of systems designed to assess the risk of and to prevent, detect and 

control the spread of a health care associated infection; 

(b) where applicable, the provision of appropriate treatment for those who are affected by a 

health care associated infection; and 

(c) the maintenance of appropriate standards of cleanliness and hygiene in relation to— 

(i) premises occupied for the purpose of carrying on the regulated activity, 

(ii) equipment and reusable medical devices used for the purpose of carrying on the 

regulated activity, and 

(iii) materials to be used in the treatment of service users where such materials are at risk 

of being contaminated with a health care associated infection. 




Management of medicines 

13. The registered person must protect service users against the risks associated with the unsafe 

use and management of medicines, by means of the making of appropriate arrangements for the 

obtaining, recording, handling, using, safe keeping, dispensing, safe administration and disposal of 

medicines used for the purposes of the regulated activity. 

Meeting nutritional needs 

14.—(1) Where food and hydration are provided to service users as a component of the carrying 

on of the regulated activity, the registered person must ensure that service users are protected from 

the risks of inadequate nutrition and dehydration, by means of the provision of— 

(a) a choice of suitable and nutritious food and hydration, in sufficient quantities to meet 

service users’ needs; 

(b) food and hydration that meet any reasonable requirements arising from a service user’s 

religious or cultural background; and 

(c) support, where necessary, for the purposes of enabling service users to eat and drink 

sufficient amounts for their needs. 

(2) For the purposes of this regulation, “food and hydration” includes, where applicable, 

parenteral nutrition and the administration of dietary supplements where prescribed. 

Safety and suitability of premises 

15.—(1) The registered person must ensure that service users and others having access to premises 

where a regulated activity is carried on are protected against the risks associated with unsafe or 

unsuitable premises, by means of— 

(a) suitable design and layout; 

(b) appropriate measures in relation to the security of the premises; and 

(c) adequate maintenance and, where applicable, the proper— 

(i) operation of the premises, and 

(ii) use of any surrounding grounds, 

which are owned or occupied by the service provider in connection with the carrying on of the 


(2) In paragraph (1), the term “premises where a regulated activity is carried on” does not 

include a service user’s own home. 

Safety, availability and suitability of equipment 

16.—(1) The registered person must make suitable arrangements to protect service users and 

others who may be at risk from the use of unsafe equipment by ensuring that equipment provided 

for the purposes of the carrying on of a regulated activity is— 

(a) properly maintained and suitable for its purpose; and 

(b) used correctly. 

(2) The registered person must ensure that equipment is available in sufficient quantities in order 

to ensure the safety of service users and meet their assessed needs. 

(3) Where equipment is provided to support service users in their day to day living, the 

registered person must ensure that, as far as reasonably practicable, such equipment promotes the 

independence and comfort of service users. 

(4) For the purposes of this regulation— 

(a) “equipment” includes a medical device; and 


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Appendix C 

(b) “medical device” has the same meaning as in the Medical Devices Regulations 2002(a). 

Respecting and involving service users 

17.—(1) The registered person must, so far as reasonably practicable, make suitable 

arrangements to ensure— 

(a) the dignity, privacy and independence of service users; and 

(b) that service users are enabled to make, or participate in making, decisions relating to their 

care or treatment. 


(a) treat service users with consideration and respect; 

(b) provide service users with appropriate information and support in relation to their care or 

treatment; 

(c) encourage service users, or those acting on their behalf, to— 

(i) understand the care or treatment choices available to the service user, and discuss 

with an appropriate health care professional, or other appropriate person, the balance 

of risks and benefits involved in any particular course of care or treatment, and 

(ii) express their views as to what is important to them in relation to the care or treatment; 

(d) where necessary, assist service users, or those acting on their behalf, to express the views 

referred to in sub-paragraph (c)(ii) and, so far as appropriate and reasonably practicable, 

accommodate those views; 

(e) where appropriate, provide opportunities for service users to manage their own care or 

treatment; 

(f) where appropriate, involve service users in decisions relating to the way in which the 

regulated activity is carried on in so far as it relates to their care or treatment; 

(g) provide appropriate opportunities, encouragement and support to service users in relation 

to promoting their autonomy, independence and community involvement; and 

(h) take care to ensure that care and treatment is provided to service users with due regard to 

their age, sex, religious persuasion, sexual orientation, racial origin, cultural and linguistic 

background and any disability they may have. 

Consent to care and treatment 

18. The registered person must have suitable arrangements in place for obtaining, and acting in 

accordance with, the consent of service users in relation to the care and treatment provided for 

them. 

Complaints 

19.—(1) For the purposes of assessing, and preventing or reducing the impact of, unsafe or 

inappropriate care or treatment, the registered person must have an effective system in place 

(referred to in this regulation as “the complaints system”) for identifying, receiving, handling and 

responding appropriately to complaints and comments made by service users, or persons acting on 

their behalf, in relation to the carrying on of the regulated activity. 

(2) In particular, the registered person must— 

(a) bring the complaints system to the attention of service users and persons acting on their 

behalf in a suitable manner and format; 

(b) provide service users and those acting on their behalf with support to bring a complaint or 

make a comment, where such assistance is necessary; 

(a) S.I. 2002/618; the relevant amending instrument is S.I. 2008/2936. 




(c) ensure that any complaint made is fully investigated and, so far as reasonably practicable, 

resolved to the satisfaction of the service user, or the person acting on the service user’s 

behalf; and 

(d) take appropriate steps to coordinate a response to a complaint where that complaint 

relates to care or treatment provided to a service user in circumstances where the 

provision of such care or treatment has been shared with, or transferred to, others. 

(3) The registered person must send to the Commission, when requested to do so, a summary of 

the— 

(a) complaints made pursuant to paragraph (1); and 

(b) responses made by the registered person to such complaints. 

Records 

20.—(1) The registered person must ensure that service users are protected against the risks of 

unsafe or inappropriate care and treatment arising from a lack of proper information about them by 

means of the maintenance of— 

(a) an accurate record in respect of each service user which shall include appropriate 

information and documents in relation to the care and treatment provided to each service 

user; and 

(b) such other records as are appropriate in relation to— 

(i) persons employed for the purposes of carrying on the regulated activity, and 

(ii) the management of the regulated activity. 

(2) The registered person must ensure that the records referred to in paragraph (1) (which may 

be in paper or electronic form) are— 

(a) kept securely and can be located promptly when required; 

(b) retained for an appropriate period of time; and 

(c) securely destroyed when it is appropriate to do so. 

Requirements relating to workers 

21. The registered person must— 

(a) operate effective recruitment procedures in order to ensure that no person is employed for 

the purposes of carrying on a regulated activity unless that person— 

(i) is of good character, 

(ii) has the qualifications, skills and experience which are necessary for the work to be 

performed, and 

(iii) is physically and mentally fit for that work; 

(b) ensure that information specified in Schedule 3 is available in respect of a person 

employed for the purposes of carrying on a regulated activity, and such other information 

as is appropriate; 

(c) ensure that a person employed for the purposes of carrying on a regulated activity is 

registered with the relevant professional body where such registration is required by, or 

under, any enactment in relation to— 

(i) the work that the person is to perform, or 

(ii) the title that the person takes or uses; and 

(d) take appropriate steps in relation to a person who is no longer fit to work for the purposes 

of carrying on a regulated activity including— 

(i) where the person is a health care professional, informing the body responsible for 

regulation of the health care profession in question, or 


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Appendix C 

Staffing 

(ii) where the person is a social care worker registered with the General Social Care 

Council, informing the Council(a). 

22. In order to safeguard the health, safety and welfare of service users, the registered person 

must take appropriate steps to ensure that, at all times, there are sufficient numbers of suitably 

qualified, skilled and experienced persons employed for the purposes of carrying on the regulated 

activity. 

Supporting workers 

23.—(1) The registered person must have suitable arrangements in place in order to ensure that 

persons employed for the purposes of carrying on the regulated activity are appropriately 

supported in relation to their responsibilities, to enable them to deliver care and treatment to 

service users safely and to an appropriate standard, including by— 

(a) receiving appropriate training, professional development, supervision and appraisal; and 

(b) being enabled, from time to time, to obtain further qualifications appropriate to the work 

they perform. 

(2) Where the regulated activity carried on involves the provision of health care, the registered 

person must (as part of a system of clinical governance and audit) ensure that healthcare 

professionals employed for the purposes of carrying on the regulated activity are enabled to 

provide evidence to their relevant professional body demonstrating, where it is possible to do so, 

that they continue to meet the professional standards which are a condition of their ability to 

practise. 

(3) For the purposes of paragraph (2), “system of clinical governance and audit” means a 

framework through which the registered person endeavours continuously to— 

(a) evaluate and improve the quality of the services provided; and 

(b) safeguard high standards of care by creating an environment in which clinical excellence 

can flourish. 

Cooperating with other providers 

24.—(1) The registered person must make suitable arrangements to protect the health, welfare 

and safety of service users in circumstances where responsibility for the care and treatment of 

service users is shared with, or transferred to, others, by means of— 

(a) so far as reasonably practicable, working in cooperation with others to ensure that 

appropriate care planning takes place; 

(b) subject to paragraph (2), the sharing of appropriate information in relation to— 

(i) the admission, discharge and transfer of service users, and 

(ii) the co-ordination of emergency procedures; and 

(c) supporting service users, or persons acting on their behalf, to obtain appropriate health 

and social care support. 

(2) Nothing in this regulation shall require or permit any disclosure or use of information which 

is prohibited by or under any enactment, or by court order. 

(a) The General Social Care Council is established under Part 5 of the Care Standards Act 2000 (c.14). See section 55 of that 

Act for the definition of “social care worker”, and S.I. 2004/561. 




Compliance with regulations 

PART 5 

COMPLIANCE AND OFFENCES 

25. Where there is more than one registered person in respect of a regulated activity, or in 

respect of that activity as carried on at or from particular premises, anything which is required 

under these Regulations to be done by the registered person shall, if done by one of the registered 

persons, not be required to be done by any of the other registered persons. 

Guidance and Code 

26.—(1) For the purposes of compliance with the requirements set out in these Regulations, the 

registered person must have regard to— 

(a) guidance issued by the Commission in relation to the requirements set out in Parts 3 and 4 

(with the exception of regulation 12 in so far as it applies to health care associated 

infections); and 

(b) in relation to regulation 12, any Code of Practice issued by the Secretary of State in 

relation to the prevention or control of health care associated infections. 

(2) For the purposes of paragraph (1)— 

(a) “guidance” means the guidance referred to in section 23 of the Act; and 

(b) “Code of Practice” means the code of practice referred to in section 21 of the Act. 

Offences 

27.—(1) A failure to comply with any of the provisions of regulations 9 to 24 shall be an 

offence. 

(2) The Commission may not bring proceedings in respect of a failure by a registered person to 

comply with any of those provisions unless— 

(a) the alleged failure is one in respect of which the Commission has given a warning notice 

to the registered person under section 29 of the Act; 

(b) that warning notice specified a time within which the registered person must take action 

to secure compliance pursuant to section 29(2)(c)(ii) of the Act; and 

(c) the registered person did not secure compliance within the specified time. 

(3) A person guilty of an offence under paragraph (1) is liable, on summary conviction, to a fine 

not exceeding £50,000. 

(4) In any proceedings for an offence under this regulation, it is a defence for the registered 

person to prove that they took all reasonable steps or exercised all due diligence to ensure that the 

provision in question was complied with. 

PART 6 

PENALTY NOTICES 

28.—(1) The offences under the provisions listed in the first column of Schedule 4 are 

prescribed as fixed penalty offences for the purposes of section 86 of the Act. 

(2) The monetary amount of the penalty for each fixed penalty offence is prescribed in the third 

column of Schedule 4. 

(3) The time by which the penalty specified in a penalty notice is to be paid is the end of the 

period of 28 days beginning with the date of receipt of the notice. 


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Appendix C 

(4) Subject to paragraph (5), the methods by which a penalty may be paid are by cash, cheque, 

credit or debit card, postal order or electronic transfer of funds to the Commission’s bank account. 

(5) A penalty may only be paid by credit or debit card from the date on which the Commission 

has in place arrangements to accept such payments. 

(6) Where a person is given a penalty notice, proceedings for the offence to which the notice 

relates may not be instituted before the end of the period of 28 days beginning with the date of 

receipt of the notice. 

(7) Section 93 of the Act applies to a penalty notice as it applies to a notice required to be given 

under Part 1 of the Act. 

(8) Where a penalty notice is given by being sent by an electronic communication, in 

accordance with section 94 of the Act, the notice is, unless the contrary is proved, to be taken to 

have been received on the next working day after the day on which it is sent. 

(9) A penalty notice must give such particulars of the circumstances alleged to constitute the 

offence as seem to the Commission to be reasonably required to provide the person to whom the 

notice is given with information about it. 

(10) A penalty notice must state— 

(a) the name and address of the person to whom the notice is given; 

(b) the amount of the penalty; 

(c) the period during which proceedings will not be taken for the offence; 

(d) that payment within that period will discharge any liability for the offence; 

(e) the consequences of the penalty not being paid before the expiration of the period for 

paying it; 

(f) the person to whom and the address at which the penalty may be paid and to which any 

correspondence about the penalty may be sent; and 

(g) the means by which payment of the penalty may be made. 

(11) The Commission may withdraw a penalty notice by giving written notice of the withdrawal 

to the person to whom the notice was given if— 

(a) the Commission determines that it ought not to have been given or it ought not to have 

been given to the person to whom it was addressed; or 

(b) it appears to the Commission that the notice contains material errors. 

(12) A penalty notice may be withdrawn in accordance with paragraph (11) whether or not the 

period for payment referred to in paragraph (3) has expired, and whether or not the penalty has 

been paid. 

(13) Where a penalty notice has been withdrawn in accordance with paragraph (11), the 

Commission must— 

(a) repay any amount paid by way of penalty in pursuance of that notice to the person who paid it, 

within 14 days beginning with the day on which written notice of the withdrawal was given; and 

(b) remove from publication any information about the payment of the penalty which has 

been published in accordance with regulations made under section 89 of the Act, within 

7 days beginning with the day on which written notice of the withdrawal was given. 

(14) Except as provided in paragraph (15), no proceedings may be instituted or continued 

against the person to whom a penalty notice was given for the offence to which the penalty notice 

relates where that notice has been withdrawn in accordance with paragraph (11). 

(15) Where a penalty notice has been withdrawn pursuant to paragraph (11)(b), proceedings 

may be instituted or continued for the offence in connection with which that penalty notice 

was issued if a further penalty notice in respect of the offence has been given and the penalty has not 

been paid before the expiration of the period for payment referred to in paragraph (3). 





“electronic communication” has the same meaning as in the Electronic Communications Act 

2000(a); 

“working day” means any day other than— 

(a) a Saturday or Sunday; 

(b) Christmas Day or Good Friday; or 

(c) a day which is a bank holiday in England and Wales under the Banking and Financial 

Dealings Act 1971(b); 

“debit card” means a card the use of which by its holder to make a payment results in a current 

account of the holder at a bank, or at any other institution providing banking services, being 

debited with the payment; 

“credit card” means a card which is a credit-token within the meaning of section 14 of the 

Consumer Credit Act 1974(c). 

Revocation 

PART 7 

REVOCATION 

29. The Health and Social Care Act 2008 (Registration of Regulated Activities) Regulations 2009(d) 

are revoked. 

Signed by authority of the Secretary of State for Health 

Mike O’Brien 

Minister of State, 

15th March 2010 Department of Health 

Personal care 

SCHEDULE 1 Regulation 3 

Regulated Activities 

1.—(1) Subject to sub-paragraphs (2) and (3), the provision of personal care for persons who, by 

reason of old age, illness or disability are unable to provide it for themselves, and which is 

provided in a place where those persons are living at the time the care is provided. 

(2) This paragraph does not apply where paragraph 2 (accommodation for persons who require 

nursing or personal care) or paragraph 4 (accommodation and nursing or personal care in the 

further education sector) applies. 

(3) The following types of provision are excepted from sub-paragraph (1)— 

(a) 2000 c.7; see section 15 as amended by the Communications Act 2003 (c.21), Schedule 17, paragraph 158. 

(b) 1971 c. 80. 

(c) 1974 c. 39. 

(d) S.I. 2009/660. 


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Appendix C 

(a) the supply of carers to a service provider by an undertaking acting as an employment 

agency or employment business for the purposes of that provider carrying on a regulated 

activity; 

(b) the introduction of carers to an individual (other than a service provider) by a person 

(including an employment agency or an employment business) having no ongoing role in 

the direction or control of the service provided to that individual; 

(c) the services of a carer employed by an individual, without the involvement of an 

undertaking acting as an employment agency or employment business, and working 

wholly under the direction and control of that individual in order to meet that individual’s 

own care requirements; and 

(d) the provision of personal care by a person managing a prison or other similar custodial 

establishment (other than a hospital within the meaning of Part 2 of the 1983 Act). 

(4) In sub-paragraph (3), “carer” means an individual who provides personal care to a person 

referred to in sub-paragraph (1). 

Accommodation for persons who require nursing or personal care 

2.—(1) The provision of residential accommodation, together with nursing or personal care. 

(2) Sub-paragraph (1) does not apply to the provision of accommodation— 

(a) to an individual by an adult placement carer under the terms of a carer agreement; 

(b) in a school; or 

(c) in an institution within the further education sector. 

Accommodation for persons who require treatment for substance misuse 

3. The provision of residential accommodation for a person, together with treatment for drug or 

alcohol misuse, where acceptance by the person of such treatment is a condition of the provision 

of the accommodation. 

Accommodation and nursing or personal care in the further education sector 

4.—(1) Subject to sub-paragraph (2), the provision of residential accommodation together with 

nursing or personal care for persons in an institution within the further education sector. 

(2) Sub-paragraph (1) only applies where the number of persons to whom nursing or personal 

care and accommodation are provided is more than one tenth of the number of students to whom 

both education and accommodation are provided. 

Treatment of disease, disorder or injury 

5.—(1) Subject to sub-paragraph (2), the provision of treatment for a disease, disorder or injury 

by or under the supervision of— 

(a) a health care professional, or a multi-disciplinary team which includes a health care 

professional; or 

(b) a social worker, or a multi-disciplinary team which includes a social worker, where the 

treatment is for a mental disorder. 

(2) The activities set out in sub-paragraph (3) are excepted from sub-paragraph (1). 

(3) The activities referred to sub-paragraph (2) are— 

(a) assessment or medical treatment for persons detained under the 1983 Act; 

(b) the provision of treatment by means of surgical procedures; 

(c) diagnostic and screening procedures; 

(d) services in slimming clinics; 




(e) the practice of alternative and complementary medicine, with the exception of the 

practice of osteopathy or chiropractic; 

(f) the provision of treatment in a sports ground or gymnasium (including associated 

premises) where it is provided for the sole benefit of persons taking part in, or attending, 

sporting activities and events; 

(g) the provision of treatment (not being first aid for the purposes of paragraph 14 of 

Schedule 2) under temporary arrangements to deliver health care to those taking part in, or 

attending, sporting or cultural events; 

(h) the provision of hyperbaric therapy, being the administration of oxygen (whether or not 

combined with one or more other gases) to a person who is in a sealed chamber which is 

gradually pressurised with compressed air, where the primary use of that chamber is— 

(i) pursuant to regulation 6(3)(b) of the Diving at Work Regulations 1997(a) or 

regulation 8 or 12 of the Work in Compressed Air Regulations 1996(b), or 

(ii) otherwise for the treatment of workers in connection with the work which they 

perform; and 

(i) the carrying on of any of the activities authorised by a licence granted by the Human 

Fertilisation and Embryology Authority under paragraph 1 of Schedule 2 to the Human 

Fertilisation and Embryology Act 1990(c). 

(4) In this paragraph— 

(a) “health care professional” means a person who is— 

(i) a medical practitioner, 

(ii) a dental practitioner, 

(iii) a dental hygienist, 

(iv) a dental therapist, 

(v) a dental nurse, 

(vi) a dental technician, 

(vii) an orthodontic therapist, 

(viii) a nurse, 

(ix) a midwife, 

(x) a biomedical scientist, 

(xi) a clinical scientist, 

(xii) an operating department practitioner, 

(xiii) a paramedic, or 

(xiv) a radiographer; 

(b) “biomedical scientist”, “clinical scientist”, “operating department practitioner”, 

“paramedic” and “radiographer” mean persons registered as such with the Health 

Professions Council pursuant to article 5 of the 2001 Order(d); 

(c) “dental practitioner” means a dentist registered as such with the General Dental Council 

pursuant to section 14 of the Dentists Act 1984(e); 

(a) S.I. 1997/2776. 

(b) S.I. 1996/1656. 

(c) 1990 c. 37. Paragraph 1 of Schedule 2 was amended by the Human Fertilisation and Embryology Act 2008 (c. 22), Schedule 

2, paragraph 2 and Schedule 8, Part I and by S.I. 2007/1522. 

(d) “Relevant professions” are set out in Schedule 3, paragraph 1 of the 2001 Order. See S.I. 2004/2033, articles 3(4)(c) and 

10(5)(b)(ii) and S.I. 2007/3101, Part 21, for relevant amendments. 

(e) Section 14 of the Dentists Act 1984 (c.24) (“the 1984 Act”) was substituted by the Dentists Act 1984 (Amendment) Order 

2005 (S.I. 2005/2011) (“the 2005 Order”), article 2(6) and amended by S.I. 2007/3101, regulation 111. 


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Appendix C 

(d) “dental hygienist”, “dental therapist”, “dental nurse”, “dental technician” and 

“orthodontic therapist” mean persons registered as such with the General Dental Council 

in the dental care professionals register(a); 

(e) “mental disorder” means any disorder or disability of the mind, including dependence on 

alcohol or drugs; 

(f) “midwife” means a registered midwife; 

(g) “social worker” means a person who is registered as such with the General Social Care 

Council pursuant to section 56(1)(a) of the Care Standards Act 2000(b). 

Assessment or medical treatment for persons detained under the 1983 Act 

6.—(1) The assessment of, or medical treatment (other than surgical procedures) for, a mental 

disorder affecting a person in a hospital where that person is— 

(a) detained in that hospital pursuant to the provisions of the 1983 Act (with the exception of 

section 135 or 136(c)); 

(b) recalled to that hospital under section 17E of that Act(d); or 

(c) detained in that hospital pursuant to an order or direction made under another enactment, 

where that detention takes effect as if the order or direction were made pursuant to the 

provisions of the 1983 Act. 

(2) In this paragraph— 

(a) “hospital” means a hospital within the meaning of Part 2 of that Act(e); 

(b) “medical treatment” has the same meaning as in section 145 of that Act(f); and 

(c) “mental disorder” has the same meaning as in section 1 of that Act(g). 

Surgical procedures 

7.—(1) Subject to sub-paragraphs (2) to (5), surgical procedures (including all pre-operative and 

post-operative care associated with such procedures) carried on by a health care professional for— 

(a) the purpose of treating disease, disorder or injury; 

(b) cosmetic purposes, where the procedure involves the use of instruments or equipment 

which are inserted into the body; or 

(c) the purpose of religious observance. 

(2) Subject to sub-paragraph (3), the following procedures are excepted from sub-paragraph 

(1)— 

(a) nail surgery and nail bed procedures carried out by a health care professional on any area 

of the foot; and 

(b) surgical procedures involving the curettage, cautery or cryocautery of warts, verrucae or 

other skin lesions carried out by— 

(i) a medical practitioner, or 

(ii) another health care professional on any area of the foot. 

(a) The dental care professionals register was established by section 36B of the 1984 Act as inserted by article 29 of the 2005 

Order and amended by S.I. 2001/3101, regulation 122. 

(b) 2000 c.14. See also S.I. 2007/3101, regulations 230 and 232(a) for relevant amendments. 

(c) Section 135 was amended by the Mental Health (Scotland) Act 1984 (c.36) Schedule 3, paragraph 56, the Police and 

Criminal Evidence Act 1984 (c.60) Schedule 6, Part 1 and Schedule 7, Part 1, the National Health Service and Community 

Care Act 1990 (c.19) Schedule 10, the Care Standards Act 2000 (c.14) Schedule 4, paragraph 9, the Mental Health Act 2007 

(“the 2007 Act”) (c.12) section 44 and Schedule 2, paragraph 10(a) and S.I. 2005/2078, Schedule 1, paragraph 2(9). 

Section 136 was amended by the 2007 Act, section 44 and Schedule 2, paragraph 10(b). 

(d) Section 17E was inserted by section 32 of the 2007 Act. 

(e) See sections 34(2) and 145(1) of the 1983 Act; relevant amendments were made by the Care Standards Act 2000, 

Schedule 4, paragraph 9. 

(f) Section 145 was amended by section 7 of the 2007 Act. 

(g) Section 1 was amended by section 1(2) of the 2007 Act. 




(3) Sub-paragraph (2) only applies where the procedures are carried out— 

(a) without anaesthesia; or 

(b) using local anaesthesia. 

(4) The following cosmetic procedures are excepted from sub-paragraph (1)(b)— 

(a) the piercing of any part of the human body; 

(b) tattooing; 

(c) the subcutaneous injection of a substance or substances for the purpose of enhancing a 

person’s appearance; and 

(d) the removal of hair roots or small blemishes on the skin by the application of heat using 

an electric current. 

Diagnostic and screening procedures 

8.—(1) Subject to sub-paragraph (3), diagnostic and screening procedures involving— 

(a) the use of X-rays and other methods in order to examine the body by the use of radiation, 

ultrasound or magnetic resonance imaging; 

(b) the use of instruments or equipment which are inserted into the body to— 

(i) view its internal parts, or 

(ii) gather physiological data; 

(c) the removal of tissues, cells or fluids from the body for the purposes of discovering the 

presence, cause or extent of disease, disorder or injury; 

(d) the use of equipment in order to examine cells, tissues and other bodily fluids for the 

purposes of obtaining information on the causes and extent of a disease, disorder or 

injury; and 

(e) the use of equipment to measure or monitor physiological data in relation to the— 

(i) audio-vestibular system, 

(ii) vision system, 

(iii) neurological system, 

(iv) cardiovascular system, 

(v) respiratory system, 

(vi) gastro-intestinal system, or 

(vii) urinary system, 

for the purposes of obtaining information on the causes and extent of a disease, disorder 

or injury, or the response to a therapeutic intervention, where such information is needed 

for the purposes of the planning and delivery of care or treatment. 

(2) Subject to sub-paragraph (3), the analysis and reporting of the results of the procedures 

referred to in sub-paragraph (1). 

(3) The procedures specified in sub-paragraph (4), and the analysis and reporting of the results 

of those procedures, are excepted from sub-paragraphs (1) and (2). 

(4) The procedures referred to in sub-paragraph (3) are— 

(a) the taking of blood samples where— 

(i) the procedure is carried out by means of a pin prick, and 

(ii) it is not necessary to send such samples for analysis to a place which is established 

for the purposes of carrying out tests or research in relation to samples of bodily 

cells, tissues or fluids; 

(b) the taking and analysis of samples of bodily tissues, cells or fluids in order to ascertain— 

(i) the existence of a genetically inherited disease or disorder, or 

(ii) the influence of an individual’s genetic variation on drug response, 


249

Appendix C 

where such procedures are part of neither the planning and delivery of care or treatment 

nor a national screening programme, other than for cancer; 

(c) the carrying out of procedures as part of a national cancer screening programme by a 

body established solely for the purpose of such a programme; 

(d) fitness screening procedures carried out in a gymnasium in order to ascertain that a 

person is sufficiently healthy to use fitness equipment or take part in fitness routines 

safely; 

(e) the taking of X-rays by chiropractors; 

(f) the use of ultrasound equipment by physiotherapists; and 

(g) the use of an auroscope. 

(5) For the purposes of this paragraph— 

(a) “chiropractor” means a person registered with the General Chiropractic Council pursuant 

to section 3, 4, 5 or 5A of the Chiropractors Act 1994(a); and 

(b) “physiotherapist” means a person registered as such with the Health Professions Council 

pursuant to article 5 of the 2001 Order. 

Management of supply of blood and blood derived products etc. 

9. The management of— 

(a) the supply of blood, blood components and blood derived products intended for 

transfusion; 

(b) the supply of tissues and tissue derived products intended for transplant, grafting or use in 

a surgical procedure; and 

(c) the matching and allocation of donor organs intended for transplant, and of stem cells and 

bone marrow intended for transfusion. 

Transport services, triage and medical advice provided remotely 

10.—(1) Transport services provided by an English NHS provider(b) by means of a vehicle 

which is designed for the primary purpose of carrying a person who requires treatment. 

(2) Medical advice in cases where immediate action or attention is needed, or triage provided, 

over the telephone or by electronic mail by a body established for that purpose. 

(3) For the purposes of this paragraph— 

(a) “triage” means the assignment of degrees of urgency to diseases, disorders or injuries in 

order to decide the order and place of treatment of service users; and 

(b) “vehicle” includes an air or water ambulance. 

Maternity and midwifery services 

11.—(1) Subject to sub-paragraph (2), maternity and midwifery services carried on by, or under 

the supervision of, a health care professional. 

(2) The following services are excepted from sub-paragraph (1)— 

(a) midwifery services, where the provision of those services is carried on by an individual— 

(i) acting on their own behalf, 

(ii) otherwise than in pursuance of the 2006 Act, and 

(iii) who provides such services only to service users in their own homes; 

(a) 1994 c. 17. Section 5A was inserted by S.I. 2007/3101, regulation 219. 

(b) See section 97(1) of the Act for the definition of “English NHS provider”. See regulation 3(6) which provides that the words 

“by an English NHS provider” cease to have effect on 1 st April 2011. 




(b) the provision of advice, information and support in relation to pregnancy, childbirth or the 

acquisition of parenting skills, where provided by a body whose primary purpose or 

function is not the provision of health care (other than that advice, information and 

support); 

(c) services provided under arrangements relating to the care of pregnant women and women 

who are breast feeding made pursuant to section 254 of, and Schedule 20 to, the 2006 Act 

(local social services authorities). 

Termination of pregnancies 

12. The termination of pregnancies. 

Services in slimming clinics 

13. Services provided in a slimming clinic consisting of the provision of advice or treatment by, 

or under the supervision of, a medical practitioner, including the prescribing of medicines for the 

purposes of weight reduction. 

Nursing care 

14.—(1) Subject to sub-paragraph (2), the provision of nursing care, including nursing care 

provided in a person’s own home which is not— 

(a) provided as part of any other regulated activity; and 

(b) exempted from being a regulated activity under any other paragraph in this Schedule. 

(2) The following types of provision are excepted from sub-paragraph (1)— 

(a) the supply of nurses to a service provider by an undertaking acting as an employment 

agency or employment business for the purposes of that provider carrying on a regulated 

activity; 

(b) the introduction of nurses to an individual (other than a service provider) by a person 

(including an employment agency or an employment business) having no ongoing role in 

the direction or control of the service provided to that individual; and 

(c) the services of a nurse employed by an individual, without the involvement of an 

undertaking acting as an employment agency or an employment business, and working 

wholly under the direction and control of that individual in order to meet that individual’s 

own nursing requirements. 

Family planning services 

15. The insertion or removal of an intrauterine contraceptive device carried out by, or under the 

supervision of, a health care professional. 

SCHEDULE 2 Regulations 3(7) and (8) 

Regulated Activities: General exceptions 

1.—(1) Any activity which is carried on— 

(a) in the course of a family or personal relationship; and 

(b) for no commercial consideration. 

(2) A family relationship includes a relationship between two persons who— 

(a) live in the same household; and 

(b) treat each other as though they were members of the same family. 


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Appendix C 

(3) A personal relationship is a relationship between or among friends. 

(4) A friend of a person (A) includes a person who is a friend of a member of A’s family. 

2. Any activity which involves the carrying on of an establishment or agency within the meaning 

of the Care Standards Act 2000(a) for which Her Majesty’s Chief Inspector of Education, 

Children’s Services and Skills is the registration authority under that Act. 

3. The provision of all medical services (including medical services provided otherwise than 

under the 2006 Act) by a provider whose sole or main purpose is the provision of primary medical 

services— 

(a) under arrangements made pursuant to the following sections of the 2006 Act— 

(i) section 3 (Secretary of State’s duty as to provision of certain services), 

(ii) section 83(2)(b) (primary medical services), 

(iii) section 92 (arrangements by Strategic Health Authorities for the provision of 

primary medical services); or 

(b) under a contract entered into pursuant to section 84 of that Act (general medical services 

contracts: introductory)(b). 

4. Subject to paragraph 5, and except where paragraph 3 applies, the provision of treatment in a 

surgery or consulting room otherwise than under arrangements made pursuant to the 2006 Act 

by— 

(a) an individual medical practitioner who also provides services (whether there or elsewhere) 

under arrangements made pursuant to the 2006 Act; or 

(b) a group of medical practitioners all of whom also provide services (whether there or 

elsewhere) under arrangements made pursuant to the 2006 Act. 

5. Paragraph 4 does not apply in relation to— 

(a) treatment carried out under anaesthesia or intravenously administered sedation; 

(b) dental treatment carried out under general anaesthesia; 

(c) obstetric services and, in connection with childbirth, medical services; 

(d) the termination of pregnancies; 

(e) cosmetic surgery, with the exception of the procedures referred to in paragraph 7(4) of 

Schedule 1; 

(f) haemodialysis or peritoneal dialysis; 

(g) endoscopy; or 

(h) the provision of hyperbaric therapy, being the administration of oxygen (whether or not 

combined with one or more other gases) to a person who is in a sealed chamber which is 

gradually pressurised with compressed air, where such therapy is carried out by or under 

the supervision or direction of a medical practitioner. 

6. The provision by a general medical practitioner (other than one who is a provider for the 

purposes of paragraph 3) of— 

(a) primary medical services under arrangements made pursuant to the sections of the 2006 

Act referred to in paragraph 3(a) and (b); or 

(b) any of the services listed in paragraph 5 in premises which are the premises used by that 

practitioner for the purpose of the provision of primary medical services under the 2006 

Act(c). 

(a) 2000 c.14. 

(b) This paragraph will cease to have effect on 1st April 2012: see regulation 3(8)(a). 

(c) This paragraph will cease to have effect on 1st April 2012: see regulation 3(8)(a). 




7. The provision of services (other than in a surgery, consulting room or hospital) involving 

treatment by medical practitioners working for the purposes of an undertaking which also provides such 

services in pursuance of the 2006 Act(a). 

8. Medical services provided (otherwise than in a hospital) only under arrangements made on 

behalf of service users by— 

(a) their employer; 

(b) a government department; or 

(c) an insurance provider with whom the service users hold an insurance policy, other than an 

insurance policy which is solely or primarily intended to provide benefits in connection 

with the diagnosis or treatment of physical or mental illness, disability or infirmity. 

9. Treatment provided in a vehicle which is operated by an ambulance provider which is not an English 

NHS body(b). 

10. Forensic medical services provided under arrangements made with a police authority as 

defined in section 101 (interpretation) of the Police Act 1996(c). 

11. Dental services— 

(a) provided as primary dental services in pursuance of Part 5 of the 2006 Act, except where 

those services are provided— 

(i) by a Primary Care Trust under section 99(2) (primary dental services) of that Act, or 

(ii) by an NHS trust or NHS foundation trust; or 

(b) of a kind which, if provided in pursuance of that Act, would be provided as primary dental 

services under Part 5, except where those services are provided in a hospital(d). 

12. Primary ophthalmic services provided under Part 6 of the 2006 Act and services of a kind which, if 

provided in pursuance of that Act, would be provided as primary ophthalmic services under that Part. 

13. Pharmaceutical services and local pharmaceutical services provided under Part 7 of the 2006 

Act and services of a kind which, if provided in pursuance of that Act, would be provided as 

pharmaceutical services or local pharmaceutical services under that Part. 

14. The provision of first aid by— 

(a) health care professionals where it is provided in unexpected or potentially dangerous 

situations requiring immediate action; 

(b) organisations established for that purpose; or 

(c) non-health care professionals trained to deliver such treatment. 

15. Defence medical and dental services being— 

(a) health or dental care provided by the Armed Services; 

(b) education and training provided by the Armed Services to service and other personnel in 

connection with the provision of health or dental care, including the maintenance of the 

clinical skills of such personnel; and 

(c) any service or facility falling within sub-paragraph (a) or (b) provided on behalf of the 

Armed Services under any agreement or arrangement made with the Armed Services. 

16. Treatment provided in a school to the pupils of that school by a nurse who is engaged and 

directed by the school. 

(a) This paragraph will cease to have effect on 1st April 2012: see regulation 3(8)(a). 

(b) This paragraph will cease to have effect on 1st April 2011: see regulation 3(8)(b). 

(c) 1996 c.16. The definition of police authority in section 101 was amended by the Greater London Authority Act 1999 (c. 

29), section 312(2). 

(d) This paragraph will cease to have effect on 1st April 2011: see regulation 3(8)(b). 


253

Appendix C 

17. In this Schedule— 

(a) “insurance provider” means— 

(i) a person regulated by the Financial Services Authority who sells insurance, or 

underwrites the risk of such insurance, or 

(ii) the agent of such a person; and 

(b) “primary dental services” includes the provision of dental implants. 

SCHEDULE 3 Regulations 4, 5, 6 and 21 

Information Required In Respect Of Persons Seeking To Carry On, Manage Or 

Work For The Purposes Of Carrying On, A Regulated Activity 

1. Proof of identity including a recent photograph. 

2. Where the certificate is required for a purpose referred to in— 

(a) section 113A(2)(b) of the Police Act 1997(a), a criminal record certificate issued under 

section 113A of that Act together with, after the appointed day and where applicable, 

relevant information relating to children or vulnerable adults; or 

(b) section 113B(2)(b) of the Police Act 1997, an enhanced criminal record certificate issued 

under section 113B of that Act together with, where applicable, suitability information 

relating to children or vulnerable adults. 

3. Satisfactory evidence of conduct in previous employment concerned with the provision of 

services relating to— 

(a) health or social care; or 

(b) children or vulnerable adults. 

4. Where a person (P) has been previously employed in a position whose duties involved work 

with children or vulnerable adults, satisfactory verification, so far as reasonably practicable, of the 

reason why P’s employment in that position ended. 

5. Satisfactory documentary evidence of any relevant qualification. 

6. A full employment history, together with a satisfactory written explanation of any gaps in 

employment. 

7. Satisfactory information about any physical or mental health conditions which are relevant to the 

person’s ability to carry on, manage or work for the purposes of, the regulated activity. 

8. For the purposes of this Schedule— 

(a) “the appointed day” means the day on which section 30 of the Safeguarding Vulnerable 

Groups Act 2006(b) comes into force; 

(b) “relevant information relating to children or vulnerable adults” has the same meaning as 

in section 31(2) and (3) of that Act; 

(c) “satisfactory” means satisfactory in the opinion of the Commission; and 

(d) “suitability information relating to children or vulnerable adults” means the information 

specified in sections 113BA and 113BB respectively of the Police Act 1997(c). 

(a) 1997 c. 50. Sections 113A and 113B were inserted by the Serious Organised Crime and Police Act 2005 (c. 15), section 

163(2), and amended by the Safeguarding Vulnerable Groups Act 2006 (c. 47), Schedule 9, Part 2, paragraphs 14(1), (2) 

and (3). 

(b) 2006 c.47. 

(c) Sections 113BA and 113BB were inserted into the Police Act 1997 by the Safeguarding Vulnerable Groups Act 2006, 

section 63(1), Schedule 9, Part 2, paragraph 14(1) and (4). 





Fixed Penalty Offences 

Provision creating offence General nature of offence Monetary amount of penalty 

Regulation 27 of these 

Regulations 

Contravention of, or failure to 

comply with, requirements 

relating to quality and safety of 

service provision in relation to a 

regulated activity 

£4,000 in the case of an offence 

committed by a service provider; 


committed by a registered 

manager 

£4,000 

Section 10(1) of the Act Carrying on a regulated activity 

without being registered 

Section 33 of the Act Failure to comply with conditions £4,000 in the case of an offence 

committed by a service provider; 


committed by a registered 

manager 

Section 34(1) of the Act Carrying on a regulated activity 

whilst registration is suspended 

£4,000 

Section 34(2), (3) or (4) of the Managing a regulated activity £2,000 

Act 

whilst registration is cancelled or 

suspended 

Section 63(7) of the Act Obstructing entry and 

inspection 

£300 

Section 64(4) of the Act Failure to provide documents 

and information 

£300 

Section 65(4) of the Act Failure to provide an explanation £300 

EXPLANATORY NOTE 

(This note is not part of the Regulations) 

These Regulations, which are to come into force on 1st April 2010, are made under the Health and 

Social Care Act 2008 (“the Act”) and prescribe the kinds of activities that will be regulated activities for 

the purposes of Part 1 of the Act, and the requirements that will apply in relation to the way in which 

those activities are carried on. Part 1 of the Act establishes the Care Quality Commission and provides 

for the registration of persons carrying on a prescribed regulated activity. It also provides powers to 

make regulations imposing requirements in relation to the carrying on of those regulated activities. 

Part 1 (regulations 1 and 2) are general provisions dealing with citation, commencement and 

interpretation. 

In Part 2, regulation 3 deals with the activities that will be regulated activities for the purposes of section 

8(1) of the Act. The activities are set out in Schedule 1 to the Regulations together with certain activity 

specific exemptions. Regulation 3(3) provides that, until 1st October 2010, an activity will only be a 

regulated activity if it is carried on by an English NHS body. Regulation 3(4) provides that where social 

care services are provided by an English NHS body which continues to be registered in respect of those 

services under the Care Standards Act 2000 then, in so far as those services are capable of being a 

regulated activity for the purposes of these Regulations, they will not be so until 1st October 2010. An 

activity is only a regulated activity if it is carried on in England (regulation 3(5)). In addition, regulation 

3(7) provides that the activities listed in Schedule 2 (general exceptions) are not to be regulated 

activities for the purposes of the Regulations. Regulation 3(6) and (8) contain provisions relating to the 

time limiting of certain specified wording and provisions in Schedules 1 and 2. 


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Appendix C 

In Part 3, regulations 4 to 7, and Schedule 3, contain requirements relating to the persons registered in 

respect of the carrying on or management of a regulated activity (“registered persons”), and require 

certain information to be available in relation to those persons. Where a regulated activity is carried on 

by a body other than a partnership, that body must nominate an individual (“the nominated individual”) 

in respect of whom this information must be available (regulation 5(2)). Regulation 7 imposes general 

requirements as to the need for appropriate training in the case of a registered person. 

Part 4 makes provision about the conduct of the regulated activity and, in particular, about the quality 

and safety of service provision including in relation to the care and welfare of service users (regulation 

9), assessing and monitoring the quality of service provision (regulation 10), safeguarding vulnerable 

service users (regulation 11), cleanliness and infection control (regulation 12), the management of 

medicines (regulation 13), the meeting of nutritional needs (regulation 14), the safety and suitability of 

premises and equipment (regulations 15 and 16), respecting and involving service users (regulation 17) 

and the obtaining of consent to care and treatment (regulation 18). Provision is also made about 

complaints (regulation 19), record keeping (regulation 20), the fitness of workers, staffing and cooperation 

with other service providers (regulations 21 to 24). 

Part 5 deals with who is responsible for complying with the regulations in circumstances where there is 

more than one registered person in respect of a regulated activity (regulation 25). Regulation 26 states 

that, for the purposes of compliance with the Regulations, a registered person must take account of 

guidance issued by the Commission under section 23 of the Act and the Code of Practice issued by the 

Secretary of State under section 21 of the Act in relation to the prevention or control of healthcare 

associated infections. Regulation 27 provides that a breach of regulations 9 to 24 is to be an offence, 

and also includes a due diligence defence relating to any proceedings under the Regulations. In 

addition, it provides that no prosecution may be brought unless the breach is one which the registered 

person has failed to remedy in response to a warning notice given under section 29 of the Act. 

In Part 6, regulation 28 (and Schedule 4) prescribe fixed penalty offences for the purposes of section 

86 of the Act and the amount of the penalty, and make provision about the time by which a penalty 

notice must be paid and the method by which the payment may be made, the period during which 

proceedings cannot be instituted for the offence to which the penalty notice relates, the content of the 

penalty notice and when a penalty notice can be withdrawn. 

In Part 7, regulation 29 revokes the Health and Social Care Act 2008 (Registration of Regulated 

Activities) Regulations 2009. 

An impact assessment of the effect that this instrument will have on the costs and benefits to the 

service providers in question, together with an Equality Screening Assessment is available on the 

Department of Health website at 

http://www.dh.gov.uk/en/Publicationsandstatistics/Legislation/index.htm and is annexed to the 

Explanatory Memorandum which is available alongside the instrument on the OPSI website. 


Appendix D: 

The Care Quality Commission (Registration) Regulations 2009 

STATUTORY INSTRUMENTS 

2009 No. 3112 

NATIONAL HEALTH SERVICE, ENGLAND 

SOCIAL CARE, ENGLAND 

PUBLIC HEALTH, ENGLAND 


Made - - - - 26th November 2009 

Laid before Parliament 30th November 2009 

Coming into force 1st April 2010 

The Secretary of State makes the following Regulations in exercise of the powers conferred by 

sections 10(2), 13(1), 16(a), 17(1), 20, 30(3), 39(1) and (4), 41(1), 42, 65(1) and (3), 89 and 161(3) and 

(4) of the Health and Social Care Act 2008(a). 

In accordance with section 20(8) of the Act, the Secretary of State has consulted such persons as he 

considers appropriate. 

Citation and commencement 

PART 1 

GENERAL 

1. These Regulations may be cited as the Care Quality Commission (Registration) Regulations 

2009 and shall come into force on 1st April 2010. 

Interpretation 

2. In these Regulations— 

“the Act” means the Health and Social Care Act 2008; 

“health service body” means an English NHS body(b), NHS Blood and Transplant(c) or the 

Health Protection Agency(d); 

“registered manager” means, in respect of a regulated activity, a person registered with the 

Commission under Chapter 2 of Part 1 of the Act as a manager in respect of that activity; 

(a) 2008 c.14. “Prescribed” and “regulations” are defined in section 97(1) of the Act. 

(b) “English NHS body” is defined in section 97(1) of the Act. 

(c) NHS Blood and Transplant was established as a Special Health Authority in October 2005 (see: S.I. 2005/2529) and is a 

cross-border Special Health Authority as defined in section 97(1) of the Act. 

(d) The Health Protection Agency was established by the Health Protection Agency Act 2004 (c. 17), section 1. 


257

Appendix D 

“registered person” means, in respect of a regulated activity, the person who is the service 

provider or a registered manager in respect of that activity; 

“relevant address” means— 

(a) where the service provider is registered to carry on the regulated activity to which the 

enforcement action relates from one address, that address; or 

(b) where the service provider is registered to carry on the regulated activity from more than 

one address, any of those addresses to which the enforcement action is relevant; 

“service provider” means, in respect of a regulated activity, a person registered with the 

Commission under Chapter 2 of Part 1 of the Act as a service provider in respect of that 

activity; 

“service user” means a person who receives services provided in the carrying on of a regulated 

activity. 

Register of regulated activities 

PART 2 

REGISTRATION 

3. The Commission must establish and maintain a register containing such information as 

appears to the Commission to be necessary to keep the public informed about the identity of 

registered persons and their carrying on of regulated activities. 

Persons to be regarded as the person carrying on a regulated activity 

4.—(1) For the purposes of Chapter 2 of Part 1 of the Act (registration in respect of the 

provision of health or social care), the following provisions apply. 

(2) Where a regulated activity is carried on by a person (A) and one or more other persons who 

are— 

(a) individuals; and 

(b) employees of A for the purpose of carrying on the regulated activity, 

A is to be regarded as the person who carries on the regulated activity. 

(3) For the purposes of paragraph (2), a person is an employee of A where that person— 

(a) is employed by A under a contract of service, an apprenticeship, a contract for services or 

otherwise than under a contract (including under a carer agreement); or 

(b) has been granted practising privileges by A. 

(4) Where the provision of services under arrangements between a body of trustees established 

for the purpose of providing services to meet the health or social care needs of a named beneficiary 

and a provider of such services falls to be regarded as a regulated activity, it is the provider and 

not the body of trustees which shall be regarded as the person who carries on that regulated 

activity. 


(a) “carer agreement” has the same meaning as in the Adult Placement Schemes (England) 

Regulations 2004(a); and 

(b) “practising privileges” means the grant, by a person managing a hospital (as defined in 

section 275 of the National Health Service Act 2006(b)), to a registered medical 

practitioner(c) of permission to practise as a medical practitioner in that hospital. 

(a) S.I. 2004/2071 to which there are amendments not relevant to these Regulations. 

(b) 2006 c.41. 

(c) The definition of “registered medical practitioner” in Schedule 1 to the Interpretation Act 1978 (c.30) has been substituted 

by S.I. 2002/3135, Schedule 1, paragraph 10 with effect from 16th November 2009. 



Registered manager condition 

5.—(1) Subject to paragraph (2), for the purposes of section 13(1) of the Act, the registration 

of a service provider in respect of a regulated activity must be subject to a registered manager 

condition where the service provider is— 

(a) a body of persons corporate or unincorporate; or 

(b) an individual who— 

(i) is not a fit person to manage the carrying on of the regulated activity, or 

(ii) is not, or does not intend to be, in full-time day to day charge of the carrying on of 


(2) Paragraph (1)(a) does not apply where the service provider is a health service body. 

(3) A service provider (P) is not a fit person to manage the carrying on of a regulated activity 

unless P— 

(a) is of good character; 

(b) is physically and mentally fit to manage the carrying on of the regulated activity; 

(c) has the necessary qualifications, skills and experience to do so; and 

(d) is able to supply to the Commission, or arrange for the availability of, information 

relating to themselves specified in Schedule 1. 

Cancellation of registration 

6.—(1) The grounds specified for the purposes of section 17(1)(e) of the Act as grounds on 

which the Commission may cancel the registration of a registered person in respect of a regulated 

activity are that the registered person— 

(a) has made a statement which is false or misleading in a material respect, or provided false 

information, in relation to any application for— 

(i) registration, or 

(ii) the variation or removal of a condition in relation to their registration; 

(b) has failed to pay any fees payable under provision under section 85 of the Act; or 

(c) if the registered person is a service provider, is not, and has not been for a continuous 

period of 12 months ending with the date of the decision to cancel registration, carrying 

on that regulated activity. 

PART 3 

PUBLICATION OF INFORMATION AND EXPLANATIONS 

Publication of information relating to enforcement action 

7.—(1) Except in the circumstances specified in paragraphs 5 to 7 of Part 1 of Schedule 2, the 

Commission must publish the information prescribed in that Part of that Schedule in the time 

prescribed in paragraph 8 of that Part. 

(2) The Commission may publish the information prescribed in Part 2 of Schedule 2 subject, in 

the case of the information prescribed in paragraph 13, to the conditions specified in sub-paragraph 

(2) of that paragraph. 

Exemptions from the requirement to notify bodies of certain matters 

8. Section 39(1) of the Act does not apply to— 

(a) a notice to a person who applies for registration as a registered person given under— 

(i) section 26(2) or (3) of the Act (notice of proposals), or 


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Appendix D 

(ii) section 28(1) or (3) of the Act (notice of decisions); 

(b) a notice of proposal given under section 26(4)(c) or (d) of the Act, or a notice of decision 

given under section 28(3) of the Act, which— 

(i) relates to the variation or removal of any condition for the time being in force in 

relation to a registration or the imposition of an additional condition in relation to a 

registration, and 

(ii) appears to the Commission not to have a material impact on the regulated activity 

being carried on; 

(c) a notice of proposal given under section 26(5) of the Act or a notice of decision given 

under section 28(3) of the Act to refuse an application by the registered person under 

section 19(1) of the Act; and 

(d) a warning notice given under section 29 of the Act which appears to the Commission not 

to have a material impact on the regulated activity being carried on. 

Notification to Primary Care Trust, English local authority and Strategic Health 

Authority 

9.—(1) The Primary Care Trust or English local authority that is required to be given— 

(a) notice of an application for an order for cancellation of the registration of a registered 

person under section 30 of the Act; or 

(b) a copy of a notice under section 39 of the Act, 

is to be determined in accordance with paragraphs (2) to (8). 

(2) Where the application under section 30 of the Act, or the notice of which a copy is required 

to be given under section 39 of the Act, is in respect of a regulated activity that involves, or is 

connected with, the provision of health care, the Commission must give notice or a copy of the 

notice to the relevant Primary Care Trust. 

(3) Where the application under section 30 of the Act, or the notice of which a copy is required 

to be given under section 39 of the Act, is in respect of a regulated activity that involves, or is 

connected with, the provision of social care, the Commission must give notice or a copy of the 

notice to the relevant local authority. 

(4) Subject to paragraph (6), the relevant Primary Care Trust is any Primary Care Trust in 

whose area the regulated activity is being carried on. 

(5) Subject to paragraph (6), the relevant local authority is any local authority in whose area the 

regulated activity is being carried on. 

(6) Where a registered service provider is carrying on a regulated activity from more than one set 

of premises, and a notice of which a copy is required to be given under section 39 of the Act is in 

respect of the carrying on of a regulated activity from particular premises— 

(a) the relevant Primary Care Trust is any Primary Care Trust in whose area those particular 

premises are situated; and 

(b) the relevant local authority is any local authority in whose area those particular premises 

are situated. 

(7) Subject to paragraph (8), the Strategic Health Authority that must be given notice under 

section 30(3)(b) of the Act or a copy of a notice under section 39(1)(b) of the Act is any Strategic 

Health Authority in whose area the regulated activity to which the application or notice relates is 

being carried on. 

(8) Where a registered service provider is carrying on a regulated activity from more than one set 

of premises and a copy of the notice required to be given to a Strategic Health Authority under 

section 39(1)(b) is in respect of the carrying on of a regulated activity from particular premises, the 

Strategic Health Authority that must be given a copy of the notice is any Strategic Health 

Authority in whose area those particular premises are situated. 



Power to require an explanation 

10.—(1) Where the Commission considers an explanation of a relevant matter(a) necessary or 

expedient for the purposes of any of its regulatory functions, the persons specified in paragraph (3) 

must, if so requested, provide an explanation of that matter to the Commission or to persons 

authorised by it. 

(2) Explanations required under paragraph (1) must be provided at such times and such places as 

may be specified by the Commission. 

(3) The persons referred to in paragraph (1) are— 

(a) a person carrying on a regulated activity; 

(b) a chair, director or employee of a person carrying on a regulated activity; 

(c) an English NHS body; 

(d) a member of an English NHS body other than an NHS foundation trust; 

(e) a member of a committee or sub-committee of an English NHS body other than an NHS 

foundation trust; 

(f) a member of a committee or sub-committee of the board of directors of an NHS 

foundation trust; 

(g) an employee of an English NHS body other than one falling within sub-paragraph (b); 

(h) a local authority; 

(i) a member or officer of a local authority; 

(j) a member of a committee or sub-committee of a local authority or a member of a joint 

committee of two or more local authorities; 

(k) an elected mayor of a local authority within the meaning given in section 39 of the Local 

Government Act 2000(b); 

(l) a person (other than a person prescribed in sub-paragraphs (b) to (k)) who is assisting in 

the carrying on of a regulated activity; 

(m) a person providing equipment or premises to a registered person; 

(n) a chair, director or employee of a person providing equipment or premises to a registered 

person; and 

(o) a person (other than a person prescribed in sub-paragraph (n)) who is assisting a person 

providing equipment or premises to a registered person. 

General 

PART 4 

REGISTRATION REQUIREMENTS 

11. A registered person must, insofar as they are applicable, comply with the requirements 

specified in regulations 12 to 20 in relation to any regulated activity in respect of which they are 

registered. 

Statement of purpose 

12.—(1) The registered person must give the Commission a statement of purpose containing 

the information listed in Schedule 3. 

(a) See section 65(2) of the Act for the definition of “relevant matter”. 

(b) 2000 c. 22; section 39 has been amended by section 66 of the Local Government and Public Involvement in Health Act 

2007 (c. 28). 


261

Appendix D 

(2) The registered person must keep under review and, where appropriate, revise the statement of 

purpose. 

(3) The registered person must provide written details of any revision to the statement of 

purpose to the Commission within 28 days of any such revision. 

Financial position 

13.—(1) Subject to paragraph (2), the service provider must take all reasonable steps to carry on 

the regulated activity in such a manner as to ensure the financial viability of the carrying on of that 

activity for the purposes of— 

(a) achieving the aims and objectives set out in the statement of purpose; and 

(b) meeting the registration requirements prescribed pursuant to section 20 of the Act. 

(2) This regulation does not apply where the service provider is— 

(a) an English local authority; or 

(b) a health service body. 

Notice of absence 

14.—(1) Subject to paragraphs (7) and (8), where— 

(a) the service provider, if the provider is the person in day to day charge of the carrying on 

of the regulated activity; or 


proposes to be absent from carrying on or managing the regulated activity for a continuous period 

of 28 days or more, the registered person must give notice in writing to the Commission of the 

proposed absence. 

(2) Except in the case of an emergency, the notice referred to in paragraph (1) must be given no 

later than 28 days before the proposed absence commences or within such shorter period as may be 

agreed with the Commission and must contain the following information in relation to the 

proposed absence— 

(a) its length or expected length; 

(b) the reason for it; 

(c) the arrangements which have been made for the management of the carrying on of the 

regulated activity during the period of absence; 

(d) the name, address and qualifications of the person who will be responsible for the 

management of the carrying on of the regulated activity during that absence; 

(e) in the case of the absence of the registered manager, the arrangements that have been, or 

are proposed to be, made for appointing another person to manage the carrying on of the 

regulated activity during that absence, including the proposed date by which the 

appointment is to be made. 

(3) Where the absence referred to in paragraph (1) arises as the result of an emergency, the 

registered person must give notice of the absence to the Commission within 5 working days of its 

occurrence specifying the matters set out in paragraph (2)(a) to (e). 

(4) Where— 

(a) the service provider, if the provider is the person in day to day charge of the carrying on 

of the regulated activity; or 


has been absent for a continuous period of 28 days or more, and the Commission has not been 

given notice of the absence, the registered person shall forthwith give notice in writing to the 

Commission specifying the matters set out in paragraph (2)(a) to (e). 



(5) The registered person must notify the Commission of the return to duty of the service 

provider or (as the case may be) the registered manager not later than 7 working days after the date 

of that return. 

(6) In this regulation “working day” means any day other than a Saturday, a Sunday, Christmas 

Day, Good Friday or a day which is a bank holiday in England and Wales within the meaning of 

the Banking and Financial Dealings Act 1971(a). 

(7) Subject to paragraph (8), this regulation does not apply where the service provider is a health 

service body. 

(8) Where the service provider is a health service body and is subject to a registered manager 

condition pursuant to regulation 5 or section 12(3) or (5) of the Act, this regulation shall have 

effect in relation any absence, proposed absence or return to duty of that registered manager. 

Notice of changes 

15.—(1) Subject to paragraph (2), the registered person must give notice in writing to the 

Commission, as soon as it is reasonably practicable to do so, if any of the following events takes 

place or is proposed to take place— 

(a) a person other than the registered person carries on or manages the regulated activity; 

(b) a registered person ceases to carry on or manage the regulated activity; 

(c) the name of a registered person (where that person is an individual) changes; 

(d) where the service provider is a partnership, any change in the membership of the partnership; 

(e) where the service provider is a body other than a partnership— 

(i) a change in the name or address of the body, 

(ii) a change of director, secretary or other similar officer of the body, or 

(iii) a change of nominated individual; 

(f) where the service provider is— 

(i) an individual, the appointment of a trustee in bankruptcy in relation to that 

individual, or 

(ii) a company or partnership, the appointment of a receiver, manager, liquidator or 

provisional liquidator in relation to that company or partnership. 

(2) Paragraph (1)(e)(ii) does not apply where the service provider is a health service body. 

(3) In this regulation, “nominated individual” means the individual who is employed as a 

director, manager or secretary of the body and whose name has been notified to the Commission 

as being the person who is responsible for supervising the management of the carrying on of the 

regulated activity by that body. 

Notification of death of service user 

16.—(1) Except where paragraph (2) applies, the registered person must notify the Commission 

without delay of the death of a service user— 

(a) whilst services were being provided in the carrying on of a regulated activity; or 

(b) as a consequence of the carrying on of a regulated activity. 

(2) Subject to paragraph (4), where the service provider is a health service body, the registered 

person must notify the Commission of the death of a service user where the death— 

(a) occurred— 

(i) whilst services were being provided in the carrying on of a regulated activity, or 

(ii) as a consequence of the carrying on of a regulated activity; and 

(a) 1971 c.80. 


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Appendix D 

(b) cannot, in the reasonable opinion of the registered person, be attributed to the course 

which that service user’s illness or medical condition would naturally have taken if that 

service user was receiving appropriate care or treatment. 

(3) Notification of the death of a service user must include a description of the circumstances of 

the death. 

(4) Paragraph (2) does not apply if, and to the extent that, the registered person has reported the 

death to the National Patient Safety Agency(a). 

(5) This regulation does not apply where regulation 17 applies. 

Notification of death or unauthorised absence of a service user who is detained or 

liable to be detained under the Mental Health Act 1983 

17.—(1) The registered person must notify the Commission without delay of the death or 

unauthorised absence of a service user who is liable to be detained by the registered person— 

(a) under the Mental Health Act 1983(b) (“the 1983 Act”); or 

(b) pursuant to an order or direction made under another enactment (which applies in relation 

to England), where that detention takes effect as if the order or direction were made 

pursuant to the provisions of the 1983 Act. 

(2) Notification of the death of a service user must include a description of the circumstances of 

the death. 


(a) references to persons “liable to be detained” include a community patient who has been 

recalled to hospital in accordance with section 17E of the 1983 Act(c), but do not include 

a patient who has been conditionally discharged and not recalled to hospital in accordance 

with section 42(d), 73(e) or 74(f) of the 1983 Act; 

(b) “community patient” has the same meaning as in section 17A of the 1983 Act(g); 

(c) “hospital” means a hospital within the meaning of Part 2 of that Act(h); and 

(d) “unauthorised absence” means an unauthorised absence from a hospital. 

Notification of other incidents 

18.—(1) Subject to paragraphs (3) and (4), the registered person must notify the Commission 

without delay of the incidents specified in paragraph (2) which occur whilst services are being 

provided in the carrying on of a regulated activity, or as a consequence of the carrying on of a 


(2) The incidents referred to in paragraph (1) are— 

(a) any injury to a service user which, in the reasonable opinion of a health care professional, 

has resulted in— 

(i) an impairment of the sensory, motor or intellectual functions of the service user 

which is not likely to be temporary, 

(ii) changes to the structure of a service user’s body, 

(iii) the service user experiencing prolonged pain or prolonged psychological harm, or 

(a) The National Patient Safety Agency is a Special Health Authority established by the National Patient Safety Agency 

(Establishment and Constitution) Order 2001 (S.I. 2001/1743), to which there are amendments which are not relevant to 

these Regulations. 

(b) 1983 c.20. 

(c) Section 17E was inserted by the Mental Health Act 2007 (c.12) (“the 2007 Act”), section 32(2). 

(d) Section 42 was amended by the 2007 Act, sections 40(2) and 55 and Schedule 11, Part 8. 

(e) Section 73 was amended by the 2007 Act, section 4(9) and S.I. 2001/3712 and 2008/2833. 

(f) Section 74 was amended by the Crime (Sentences) Act 1997 (c. 43), Schedule 4, paragraphs 12(10) to (12), the Criminal 

Justice Act 2003 (c. 44), section 295 and S.I. 2008/2833. 

(g) Section 17A was inserted by section 32(2) of the 2007 Act. 

(h) See sections 34(2) and 145(1) of the 1983 Act; relevant amendments were made by the Care Standards Act 2000, 

Schedule 4, paragraph 9 and by the National Health Service (Consequential Provisions) Act 2006 (c.43), Schedule 1, 

paragraph 70(c). 



(iv) the shortening of the life expectancy of the service user; 

(b) any injury to a service user which, in the reasonable opinion of a health care professional, 

requires treatment by that, or another, health care professional in order to prevent— 

(i) the death of the service user, or 

(ii) an injury to the service user which, if left untreated, would lead to one or more of the 

outcomes mentioned in sub-paragraph (a); 

(c) any request to a supervisory body made pursuant to Part 4 of Schedule A1 to the 2005 

Act by the registered person for a standard authorisation, including the result of such a 

request; 

(d) any application made to a court in relation to depriving a service user of their liberty 

pursuant to section 16(2)(a) of the 2005 Act; 

(e) any abuse or allegation of abuse in relation to a service user; 

(f) any incident which is reported to, or investigated by, the police; 

(g) any event which prevents, or appears to the service provider to be likely to threaten to 

prevent, the service provider’s ability to continue to carry on the regulated activity safely, 

or in accordance with the registration requirements, including— 

(i) an insufficient number of suitably qualified, skilled and experienced persons being 

employed for the purposes of carrying on the regulated activity, 

(ii) an interruption in the supply to premises owned or used by the service provider for 

the purposes of carrying on the regulated activity of electricity, gas, water or 

sewerage where that interruption has lasted for longer than a continuous period of 24 

hours, 

(iii) physical damage to premises owned or used by the service provider for the purposes 

of carrying on the regulated activity which has, or is likely to have, a detrimental 

effect on the treatment or care provided to service users, and 

(iv) the failure, or malfunctioning, of fire alarms or other safety devices in premises 

owned or used by the service provider for the purposes of carrying on the regulated 

activity where that failure or malfunctioning has lasted for longer than a continuous 

period of 24 hours. 

(3) Paragraph (2)(f) does not apply where the service provider is an English NHS body. 

(4) Where the service provider is a health service body, paragraph (1) does not apply if, and to 

the extent that, the registered person has reported the incident to the National Patient Safety 

Agency. 


(a) “the 2005 Act” means the Mental Capacity Act 2005(a); 

(b) “abuse”, in relation to a service user, means— 

(i) sexual abuse, 

(ii) physical or psychological ill-treatment, 

(iii) theft, misuse or misappropriation of money or property, or 

(iv) neglect and acts of omission which cause harm or place at risk of harm; 

(c) “health care professional” means a person who is registered as a member of any profession 

to which section 60(2) of the Health Act 1999(b) applies; 

(d) “registration requirements” means any requirements or conditions imposed on the 

registered person by or under Chapter 2 of Part 1 of the Act; 

(e) “standard authorisation” has the meaning given under Part 4 of Schedule A1 to the 2005 Act; 

(a) 2005 c. 9. Schedule A1 was inserted by Schedule 7 to the Mental Health Act 2007 (c. 12). 

(b) 1999 c. 8. Section 60(2) was amended by the Health and Social Care Act 2008, Schedule 8, paragraph 1(3) and Schedule 

15, Part 2 and by S.I. 2002/253 and 254. 


265

Appendix D 

(f) “supervisory body” has the meaning given in paragraph 180 (in relation to a hospital in 

England) or paragraph 182 (in relation to a care home) of Schedule A1 to the 2005 Act; 

(g) for the purposes of paragraph (2)(a)— 

(i) “prolonged pain” and “prolonged psychological harm” means pain or harm which a 

service user has experienced, or is likely to experience, for a continuous period of at 

least 28 days, and 

(ii) a sensory, motor or intellectual impairment is not temporary if such an impairment has 

lasted, or is likely to last, for a continuous period of at least 28 days. 

Fees etc. 

19.—(1) Where a service user will be responsible for paying the costs of their care or treatment 

(either in full or partially), the registered person must provide a statement to the service user, or to a 

person acting on the service user’s behalf— 

(a) specifying the terms and conditions in respect of the services to be provided to the service 

user, including as to the amount and method of payment of fees; and 

(b) including, where applicable, the form of contract for the provision of services by the service 

provider. 

(2) The statement referred to in paragraph (1) must be— 

(a) in writing; and 

(b) as far as reasonably practicable, provided prior to the commencement of the services to which 

the statement relates. 

Requirements relating to termination of pregnancies 

20.—(1) This regulation applies to a registered person who— 

(a) carries on or manages the regulated activity consisting of the termination of pregnancies; and 

(b) is not an English NHS body. 

(2) The registered person must ensure that, unless two certificates of opinion have been received in 

respect of the service user— 

(a) no termination of pregnancy is carried out; and 

(b) no fee is demanded or accepted from a service user. 

(3) The registered person must ensure that a certificate of opinion in respect of a service user 

undergoing termination of a pregnancy is completed and included with the service user’s medical 

record. 

(4) The registered person must ensure that no termination of pregnancy is undertaken after the 20th 

week of gestation, unless— 

(a) the service user is treated by persons who are suitably qualified, skilled and experienced in the 

late termination of pregnancy; and 

(b) appropriate procedures are in place to deal with any medical emergency which occurs during or 

as a result of the termination. 

(5) The registered person must ensure that no termination of a pregnancy is undertaken after the 

24th week of gestation. 

(6) The registered person must ensure that a register of service users undergoing a termination of 

pregnancy is maintained, which is— 

(a) completed in respect of each service user at the time the termination is undertaken; and 

(b) retained for a period of not less than 3 years beginning on the date of the last entry. 

(7) The registered person must ensure that a record is maintained of the total numbers of 

terminations of pregnancies undertaken. 



(8) The registered person must ensure that the record referred to in paragraph (7) (which may be in 

paper or electronic form) is— 

(a) accurate; 

(b) kept securely and can be located promptly when required; 

(c) retained for an appropriate period of time; and 

(d) securely destroyed when it is appropriate to do so. 

(9) The registered person must ensure that notice in writing is sent to the Chief Medical Officer of 

the Department of Health of each termination of pregnancy(a). 

(10) If the registered person— 

(a) receives information concerning the death of a service user who has undergone termination of 

a pregnancy during the period of 12 months ending on the date on which the information is 

received; and 

(b) has reason to believe that the service user’s death may be associated with the termination, 

the registered person must give notice in writing to the Commission of that information, within the 

period of 14 days beginning on the day on which the information is received. 

(11) The registered person must prepare and implement appropriate procedures to ensure that 

foetal tissue is treated with respect. 

(12) In this regulation, “certificate of opinion” means a certificate required by regulations made under 

section 2(1) of the Abortion Act 1967(b). 

Death of service provider 

PART 5 

OTHER MISCELLANEOUS REQUIREMENTS 

21.—(1) Where the service provider is a partnership and a partner dies, the surviving partner shall 

without delay notify the Commission of the death in writing. 

(2) Where the service provider is an individual and that individual dies, that individual’s personal 

representative must notify the Commission in writing— 

(a) without delay of the death; and 

(b) within 28 days of the date of death of their intentions regarding the future carrying on of the 


(3) The personal representative of the deceased service provider may carry on the regulated activity 

without being registered in respect of it— 

(a) for a period not exceeding 28 days; and 

(b) for any future period as may be determined in accordance with paragraph (4). 

(4) The Commission may extend the period specified in paragraph (3)(a) by such further period, not 

exceeding one year, as the Commission shall determine, and shall notify any such determination to the 

personal representative in writing. 

(5) The personal representative of the deceased service provider shall appoint a person to take fulltime 

day to day charge of the carrying on of the regulated activity during any period in which, in 

accordance with paragraph (3), they carry on the regulated activity without being registered in respect 

of it. 

(a) See section 4 of the Abortion Act 1967 (c.87) which requires such notice to be given by the medical practitioner carrying 

out the termination. For relevant amendments see: S.I. 2002/887. 

(b) The Regulations made under section 2 are S.I. 1991/499. Relevant amending instrument is S.I. 2002/887. 


267

Appendix D 

Appointment of liquidators 

22.—(1) Any person to whom paragraph (2) applies must— 

(a) notify the Commission of their appointment and the reasons for their appointment; 

(b) appoint a manager to manage the regulated activity in any cases where there is not a 

registered manager; and 

(c) before the end of the period of 28 days beginning with the date of their appointment, notify 

the Commission of their intentions regarding the future carrying on of the regulated activity. 

(2) This paragraph applies to any person appointed as— 

(a) a receiver or manager of the property of the relevant company(a); 

(b) the liquidator or provisional liquidator of a relevant company; or 

(c) the trustee in bankruptcy of a relevant individual(b). 

Compliance with regulations 

PART 6 

COMPLIANCE, GUIDANCE AND OFFENCES 

23. Where there is more than one registered person in respect of a regulated activity, or in respect of 

that activity as carried on at or from particular premises, anything which is required under these 

Regulations to be done by the registered person shall, if done by one of the registered persons, not be 

required to be done by any of the other registered persons. 

Guidance 

24.—(1) For the purposes of compliance with the requirements set out in these Regulations, the 

registered person must have regard to guidance issued by the Commission in relation to the 

requirements set out in Part 4 of these Regulations. 

(2) For the purposes of paragraph (1), “guidance” means the guidance referred to in section 23 of 

the Act. 

Offences 

25.—(1) A contravention of, or failure to comply with, any of the provisions of regulations 12 and 14 

to 20 shall be an offence. 

(2) A person guilty of an offence under paragraph (1) is liable, on summary conviction, to a fine not 

exceeding level 4 on the standard scale. 

Signed by authority of the Secretary of State for Health 

26th November 2009 

(a) See section 41(3) of the Act for the definitions of “company” and “relevant company”. 

(b) See section 41(3) of the Act for the definition of “relevant individual”. 

Mike O’Brien 

Minister of State, 

Department of Health 




INFORMATION REQUIRED IN RESPECT OF A SERVICE 

PROVIDER WHO PROPOSES TO MANAGE THE CARRYING ON OF 

A REGULATED ACTIVITY 

1. Proof of identity including a recent photograph. 

2. Where the certificate is required for a purpose referred to in— 

(a) section 113A(2)(b) of the Police Act 1997(a), a criminal record certificate issued under section 

113A of that Act together with, after the appointed day and where applicable, relevant 

information relating to children or vulnerable adults; or 

(b) section 113B(2)(b) of the Police Act 1997, an enhanced criminal record certificate issued 

under section 113B of that Act together with, where applicable, suitability information relating 

to children or vulnerable adults. 

3. Satisfactory evidence of conduct in previous employment concerned with the provision of services 

relating to— 

(a) health or social care; or 

(b) children or vulnerable adults. 

4. Where a person (P) has been previously employed in a position whose duties involved work with 

children or vulnerable adults, satisfactory verification, so far as reasonably practicable, of the reason why 

P’s employment in that position ended. 

5. Satisfactory documentary evidence of any relevant qualification. 

6. A full employment history, together with a satisfactory written explanation of any gaps in 

employment. 

7. Satisfactory information about any physical or mental health conditions which are relevant to the 

person’s ability to manage the carrying on of the regulated activity. 

8. For the purposes of this Schedule— 

(a) “the appointed day” means the day on which section 30 of the Safeguarding Vulnerable 

Groups Act 2006(b) comes into force; 

(b) “relevant information relating to children or vulnerable adults” has the same meaning as in 

section 31(2) and (3) of that Act; 

(c) “satisfactory” means satisfactory in the opinion of the Commission; and 

(d) “suitability information relating to children or vulnerable adults” means the information 

specified in sections 113BA and 113BB respectively of the Police Act 1997(c). 

(a) 1997 c. 50. Sections 113A and 113B were inserted by the Serious Organised Crime and Police Act 2005 (c. 15), section 

163(2), and amended by the Safeguarding Vulnerable Groups Act 2006 (c. 47), Schedule 9, Part 2, paragraphs 14(1), (2) 

and (3). 

(b) 2006 c. 47. 

(c) Sections 113BA and 113BB were inserted into the Police Act 1997 by the Safeguarding Vulnerable Groups Act 2006, section 

63(1), Schedule 9, Part 2, paragraph 14(1) and (4). 


269

Appendix D 


PUBLICATION OF INFORMATION RELATING TO ENFORCEMENT ACTION 

PART 1 

INFORMATION RELATING TO ENFORCEMENT ACTION WHICH MUST BE 

PUBLISHED 

1. In relation to the cancellation or suspension of a registered person’s registration under section 17, 

18, 30 or 31 of the Act, the prescribed information, subject to paragraph 5, is— 

(a) a description of the regulated activity to which the cancellation or suspension relates; 

(b) the name of the service provider in respect of that regulated activity; 

(c) where the cancellation or suspension relates to a registered manager, the name of the 

registered manager; 

(d) an explanation of why the registration has been cancelled or suspended and, where applicable, 

the period of suspension; and 

(e) the relevant address. 

2. In relation to the conviction of any person in respect of an offence under Part 1 of the Act, except 

an offence under section 76 (disclosure of confidential personal information: offence), the prescribed 

information, subject to paragraph 6, is— 

(a) a description of the offence; 

(b) a description of the regulated activity that the person so convicted is carrying on, or involved in 

carrying on; 

(c) the name of the service provider in respect of that regulated activity; 

(d) where the person convicted is the registered manager, the name of the registered manager; 



3.—(1) This paragraph applies to a decision under section 12(5) of the Act to vary or remove a 

condition for the time being in force in relation to a person’s registration, or to impose an additional 

condition, which— 

(a) takes effect from the time when the notice is given in accordance with section 31 of the Act; 

or 

(b) appears to the Commission to have a material impact on the regulated activity being carried on. 

(2) The prescribed information, subject to paragraph 5, in cases to which this paragraph applies is— 

(a) a description of the regulated activity that the variation or removal of a condition, or the 

imposition of an additional condition, relates to; 


(c) where the decision relates to a condition in respect of a registered manager, the name of the 

registered manager; 

(d) a description of the condition being varied, removed or imposed and, where applicable, the 

variation or removal; 

(e) an explanation of why the decision was taken; and 

(f) the relevant address. 



4. In relation to the payment by any person of a penalty in accordance with a penalty notice issued 

under section 86 of the Act other than in respect of an offence under section 63(7), 64(4) or 65(4) of 

that Act, the prescribed information, subject to paragraph 7, is— 

(a) a description of the fixed penalty offence; 

(b) a description of the regulated activity that the person given the penalty notice was carrying on 

or involved in carrying on; 

(c) the name of the service provider in respect of that regulated activity; 

(d) where the penalty notice is given to a registered manager, the name of the registered 

manager; and 


5. Paragraphs 1 and 3 do not apply, and the information prescribed in that paragraph must not be 

published, where an appeal is brought under section 32 of the Act and the First-tier Tribunal has 

directed that the Commission’s decision is not, or is to cease, to have effect, or the order made by a 

justice of peace is to cease to have effect. 

6. Paragraph 2 does not apply, and the information prescribed in that paragraph must not be 

published, where an appeal is brought against a conviction for an offence under Part 1 of the Act and 

the conviction is quashed. 

7. Paragraph 4 does not apply, and the information prescribed in that paragraph must not be 

published, where a penalty notice is withdrawn in accordance with regulations made under section 

87(1)(e) of the Act after the penalty has been paid but before publication of the information prescribed 

in paragraph 4. 

8.—(1) The time prescribed for information required to be published under paragraphs 1 and 3 

where no appeal is brought under section 32 of the Act is within the period starting immediately after 

the end of the period of 28 days referred to in section 32(2) of the Act and ending 4 months after 

service on the person of the notice of the Commission’s decision or the date of the order under section 

30 of the Act. 

(2) The time prescribed for information required to be published under paragraphs 1 and 3 where an 

appeal is brought under section 32 of the Act is within 3 months of the determination or abandonment 

of the appeal. 

(3) The time prescribed for information required to be published under paragraph 2 where no appeal 

is brought against a conviction is within the period starting immediately after the end of the period of 28 

days after the date of the conviction and ending 4 months after the date of the conviction. 

(4) The time prescribed for information required to be published under paragraph 2 where an appeal 

is brought against a conviction is within 3 months of the determination or abandonment of the appeal. 

(5) The time prescribed for information to be published under paragraph 4 is within 3 months of the 

date of payment of the penalty. 

PART 2 

INFORMATION RELATING TO ENFORCEMENT ACTION WHICH MAY BE 

PUBLISHED 

9. In relation to a conviction in respect of an offence under Part 1 of the Act, except an offence under 

section 76, the prescribed information is the penalty imposed. 

10. In relation to decisions under section 12(5) of the Act which do not fall within paragraph 3(1), the 

prescribed information is the information listed in paragraph 3(2)(a) to (f). 


271

Appendix D 

11. Where a person who is not a registered person is convicted of an offence under Part 1 of the Act, 

except an offence under section 76, the prescribed information is the name of, and such other details 

as the Commission considers relevant about, the individual convicted of the offence. 

12. In relation to the payment by any person of a penalty in accordance with a penalty notice issued 

under section 86 of the Act in respect of an offence under section 63(7), 64(4) or 65(4) of that Act, 

which is committed in connection with the carrying on of a regulated activity, the prescribed information 

is the information listed in paragraph 4(a) to (e). 

13.—(1) In relation to a warning notice given under section 29 of the Act, the prescribed information 

is— 

(a) a description of the regulated activity to which the warning notice relates; 


(c) where the warning notice is given to a registered manager, the name of the registered 

manager; 

(d) a description of the conduct which appears to the Commission to constitute a failure to comply 

with the relevant requirements and a description of the requirements concerned; and 


(2) Before publishing the information prescribed under sub-paragraph (1), the Commission must— 

(a) provide the person to whom the notice was given an opportunity to make representations to 

the Commission relating to the matters dealt with in the notice; and 

(b) take any such representations into account when determining whether to publish the 

prescribed information. 


INFORMATION TO BE INCLUDED IN THE STATEMENT OF 

PURPOSE 

1. The aims and objectives of the service provider in carrying on the regulated activity. 

2. The kinds of services provided for the purposes of the carrying on of the regulated activity and the 

range of service users’ needs which those services are intended to meet. 

3. The full name of the service provider and of any registered manager, together with their business 

address, telephone number and, where available, electronic mail addresses. 

4. The legal status of the service provider. 

5. Details of the locations at which the services provided for the purposes of the regulated activity are 

carried on. 

EXPLANATORY NOTE 

(This note is not part of the Regulations) 

These Regulations, which are to come into force on 1st April 2010, are made under the Health and 

Social Care Act 2008 (“the Act”) and apply in relation to regulated activities carried on in England. Part 1 

of the Act establishes the Care Quality Commission (“the Commission”) and provides for the 

registration of persons carrying on a regulated activity. 



Part 1 of the Regulations contains provisions relating to citation, commencement and interpretation 

(regulations 1 and 2). 

Part 2 of the Regulations contains provisions relating to registration. Regulation 3 requires the 

Commission to keep a register of persons registered with the Commission under Chapter 2 of Part 1 of 

the Act as a service provider or a manager in respect of a regulated activity and regulation 4 contains 

details of the persons to be regarded as carrying on the regulated activity for the purposes of Chapter 2 

of Part 1 of the Act (registration in respect of the provision of health or social care). Regulation 5 (and 

Schedule 1) sets out the circumstances in which the registration of a service provider is to be subject to 

a registered manager condition. Regulation 6 specifies the grounds on which the Commission may 

cancel a service provider’s registration pursuant to section 17(1)(e) of the Act. 

Part 3 contains provisions relating to the publication of information and explanations. Regulation 7 (and 

Schedule 2) prescribe information relating to enforcement action that the Commission must publish and 

the time by which it must be published, and information that the Commission may publish. Regulation 8 

prescribes cases in which copies of notices of proposals given under section 26 of the Act, notices of 

decisions given under section 28 of the Act and warning notices given under section 29 of the Act do 

not need to be given to persons listed in section 39 of the Act. Regulation 9 defines which Primary Care 

Trust, local authority and Strategic Health Authority is required to be notified by the Commission of an 

application for an order for cancellation of the registration of a service provider under section 30 of the 

Act or given a copy of a notice referred to in section 39(2) of the Act. Regulation 10 enables the 

Commission to require the persons prescribed to provide an explanation of a relevant matter to the 

Commission, or to persons authorised by it, in circumstances where the Commission considers the 

explanation necessary or expedient for the purposes of its regulatory functions. It also gives the 

Commission power to require the explanation to be given at such times and such places as it specifies. 

Part 4 contains registration requirements. Regulation 11 provides that a registered person must 

comply with the requirements contained in regulations 12 to 20 in so far as they apply to an 

activity in respect of which they are registered. Regulation 12 provides that the registered person 

must give to the Commission a statement of purpose containing the information set out in 

Schedule 3 and regulation 13 contains provision as to the financial viability of a service provider 

(excluding English local authorities or a health service body). Regulations 14 and 15 require the giving 

of notices to the Commission in relation to the absence of a registered person and in relation to certain 

changes affecting the carrying on of the regulated activity. Regulations 16 and 17 prescribe the 

circumstances in which notification of the death of a service user must be given to the Commission (and 

regulation 17 also requires notification of the unauthorised absence of a service user who is liable to be 

detained under the Mental Health Act 1983) and regulation 18 prescribes the incidents, occurring 

whilst services are being provided in the carrying on of a regulated activity, or as a consequence of the 

carrying on of a regulated activity, which must be notified to the Commission. Regulation 19 deals with 

information to be given to service users in relation to fees for care or treatment. Regulation 20 contains 

requirements relating to a registered person who carries on the regulated activity of termination of 

pregnancies. 

Part 5 contains other miscellaneous requirements. Regulation 21 deals with the notification to be given 

to the Commission where a service provider dies. Regulation 22 contains provisions which apply where a 

liquidator or similar person has been appointed in relation to the carrying on of a regulated activity. 

Part 6 contains provisions relating to compliance, guidance and offences. Regulation 23 deals with who 

is responsible for complying with the Regulations in circumstances where there is more than one 

registered person in respect of a regulated activity. Regulation 24 states that, for the purposes of 

compliance with the Regulations, a registered person must take account of guidance issued by the 

Commission under section 23 of the Act. Regulation 25 provides that a breach of certain of the 

requirements in the Regulations is to be an offence punishable, on summary conviction, with a fine not 

exceeding level 4 on the standard scale. 


273

Appendix D 

An impact assessment of the effect that this instrument will have on the costs and benefits to the 

service provider in question, together with an Equality Screening Assessment was published alongside 

a draft Statutory Instrument entitled the Health and Social Care Act 2008 (Regulated Activities) 

Regulations 2009 and is available on the Department of Health website at 

http://dh.gov.uk/en/Publicationsandstatistics/Legislation/index.htm. 


© Care Quality Commission 2010. 

Published March 2010. 

This document may be reproduced in whole or in part in any format or medium for 

non-commercial purposes, provided that it is reproduced accurately and not used in 

a derogatory manner or in a misleading context. The source should be acknowledged, 

by showing the document title and © Care Quality Commission 2010. 

ISBN: 978-1-84562-264-0

Need help? 

If you have any questions about applying for 

registration or you need more information, 

you can: 

● Look at our website: www.cqc.org.uk 

● Speak to your local assessment team 

or relationship manager 

● Call our National Contact Centre on 

03000 616161 

● Email us at enquiries@cqc.org.uk 

● Write to us at: 


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